Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The tires of the above scooters can burst. the manufacturer sent a security alert notification dated december 8, 2000. the company will not provide any information to ecri.
Acción
Verify receipt of the security alert notification dated December 8, 2000, submitted by Pride Mobility Products. Identify and isolate all affected products in inventory. For more information, contact your local representative or visit http://www.pridemobility.com/Foreign/foreign.html for a list of contact numbers
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Systems for infant hyperthermia have plastic cable connectors that can become brittle and break during the time of use. pieces of these broken connectors may fall from the radiation heater above into the babytherm mattress.
Acción
Please verify receipt of the letter and the response card dated March 9, 2001 from Draeguer Medical. Draeger Medical recommends that the Babytherm 8004/8010 mattress area be inspected immediately for pieces of plastic that may have fallen from the radiation heater located directly above the mattress. Draeger Medical claims that if the cable connectors become brittle and break, moving the unit can cause more breakage and falling of the pieces. All consumers must complete and return the reply card by mail at the address of the distributor above. DraegerService will contact you to arrange the replacement of plastic cable connectors with metal clips. The manufacturer has initiated a correction by letter dated March 9, 2001. For more information, contact your local Draeger Medical representative.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above monitors may drop when a user attempts to tilt the top of the monitor to an angle that exceeds 5o forward or 45o backward relative to its vertical position. the monitor is not secure at the base. there is no associated risk to the patient, as long as the monitor is not installed in the vicinity of the patient; however, a greater risk of physical injury to the patient or to the user may exist when the monitor is maneuvered because it is in an unstable position, which can cause the monitor to drop. the manufacturer initiated the correction by letter dated june 28, 2001.
Acción
Please verify receipt of a letter dated June 28, 2001 from Datascope. Identify and isolate all affected products in your inventory. Your local Datascope representative will upgrade your monitor by adding a stabilization plate to its base that will prevent the unit from overturning. In addition, your operator's manual will be updated to alert the user to use a device at the base of the monitor if it is intended to tilt the monitor head more than 45o to prevent it from falling backwards. This work will be free. For more information, contact your local representative or directly with Datascope at 1 (201) 995-8237 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Systems for infant hyperthermia have plastic cable connectors that can become brittle and break during the time of use. pieces of these broken connectors may fall from the radiation heater above into the babytherm mattress.
Acción
Please verify receipt of the letter and the response card dated March 9, 2001 from Draeguer Medical. Draeger Medical recommends that the Babytherm 8004/8010 mattress area be inspected immediately for pieces of plastic that may have fallen from the radiation heater located directly above the mattress. Draeger Medical claims that if the cable connectors become brittle and break, moving the unit can cause more breakage and falling of the pieces. All consumers must complete and return the reply card by mail at the address of the distributor above. DraegerService will contact you to arrange the replacement of plastic cable connectors with metal clips. The manufacturer initiated a correction by letter dated March 9, 2001. For more information, contact your local Draeger Medical representative
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Sera from weakly reactive controls from venereal disease research laboratories (vdrl) demonstrated comparable reactivity to, or stronger than, vdrl positive control sera. the exacerbated and unexpected reactivity of this control invalidates the assay and the user can not qualify the antigen suspension. the manufacturer commenced removal by letter dated june 2001.
Acción
Verify receipt of a letter dated June 2001 from BD Diagnostic Systems. Identify and isolate all affected products in your inventory. For more information, please contact your local representative. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Sera from weakly reactive controls from venereal disease research laboratories (vdrl) demonstrated comparable reactivity to, or stronger than, vdrl positive control sera. the exacerbated and unexpected reactivity of this control invalidates the assay and the user can not qualify the antigen suspension. the manufacturer commenced removal by letter dated june 2001.
Acción
Verify receipt of a letter dated June 2001 from BD Diagnostic Systems. Identify and isolate all affected products in your inventory. For more information, please contact your local representative. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The electrical wires in the above beds may become hot, smoke or melt during normal operation. the manufacturer initiated a patch distributing the replacement wires and ups instructions to the home of all patients with affected beds. in addition, all service centers have received an inventory of wires to exchange current wires in their service centers.
Acción
Service centers must verify that they have received Hill-Rom substitutes. Hill-Rom technicians are following the patients to see if correction procedures have been performed. If there is any affected product in your inventory that still has an affected cord or if you would like more information, contact your local representative
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above monitors may drop when a user attempts to tilt the top of the monitor to an angle that exceeds 5o forward or 45o backward relative to its vertical position. the monitor is not secure at the base. there is no associated risk to the patient, as long as the monitor is not installed in the vicinity of the patient; however, a greater risk of physical injury to the patient or to the user may exist when the monitor is maneuvered because it is in an unstable position, which can cause the monitor to drop. the manufacturer initiated the correction by letter dated june 28, 2001.
Acción
Please verify receipt of a letter dated June 28, 2001 from Datascope. Identify and isolate all affected products in your inventory. Your local Datascope representative will upgrade your monitor by adding a stabilization plate to its base that will prevent the unit from overturning. In addition, your operator's manual will be updated to alert the user to use a device at the base of the monitor if it is intended to tilt the monitor head more than 45o to prevent it from falling backwards. This work will be free. For more information, contact your local representative or directly with Datascope at 1 (201) 995-8237 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
When a strong and abrupt movement is applied to the restrictive struts, the buckle lock can open, releasing the strings and possibly allowing the patient to escape, injure or injure someone. the manufacturer has not received any injury notification involving these products until then, but failure to take immediate action to return these products can result in serious injury to the patient or others. the manufacturer initiated this correction by letter dated july 25, 2001.
Acción
Verify receipt of the letter and the corrected medical product response form dated July 25, 2001 and the JT Posey Prepaid Automated UPS Return Label. Identify and isolate all affected products in your inventory. Complete the response form and return it with any affected product to the address above using the return label. Upon return of the affected product, the manufacturer will ship replacement products to your facility at no charge. If you have distributed any of these products to customers or other locations, please provide JT Posey, by post or fax, with the name, address, telephone number, contact name, date of purchase, quantity and model number of products purchased by each consumer. For more information, contact your local representative or directly with the manufacturer at jlidikay@posey.com
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
When a strong and abrupt movement is applied to the restrictive struts, the buckle lock can open, releasing the strings and possibly allowing the patient to escape, injure or injure someone. the manufacturer has not received any injury notification involving these products until then, but failure to take immediate action to return these products can result in serious injury to the patient or others. the manufacturer initiated this correction by letter dated july 25, 2001.
Acción
Verify receipt of the letter and the corrected medical product response form dated July 25, 2001 and the JT Posey Prepaid Automated UPS Return Label. Identify and isolate all affected products in your inventory. Complete the response form and return it with any affected product to the address above using the return label. Upon return of the affected product, the manufacturer will ship replacement products to your facility at no charge. If you have distributed any of these products to customers or other locations, please provide JT Posey, by post or fax, with the name, address, telephone number, contact name, date of purchase, quantity and model number of products purchased by each consumer. For more information, contact your local representative or directly with the manufacturer at jlidikay@posey.com
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
When a strong and abrupt movement is applied to the restrictive struts, the buckle lock can open, releasing the strings and possibly allowing the patient to escape, injure or injure someone. the manufacturer has not received any injury notification involving these products until then, but failure to take immediate action to return these products can result in serious injury to the patient or others. the manufacturer initiated this correction by letter dated july 25, 2001.
Acción
Verify receipt of the letter and the corrected medical product response form dated July 25, 2001 and the JT Posey Prepaid Automated UPS Return Label. Identify and isolate all affected products in your inventory. Complete the response form and return it with any affected product to the address above using the return label. Upon return of the affected product, the manufacturer will ship replacement products to your facility at no charge. If you have distributed any of these products to customers or other locations, please provide JT Posey, by post or fax, with the name, address, telephone number, contact name, date of purchase, quantity and model number of products purchased by each consumer. For more information, contact your local representative or directly with the manufacturer at jlidikay@posey.com.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
When a strong and abrupt movement is applied to the restrictive struts, the buckle lock can open, releasing the strings and possibly allowing the patient to escape, injure or injure someone. the manufacturer has not received any injury notification involving these products until then, but failure to take immediate action to return these products can result in serious injury to the patient or others. the manufacturer initiated this correction by letter dated july 25, 2001.
Acción
Verify receipt of the letter and the corrected medical product response form dated July 25, 2001 and the JT Posey Prepaid Automated UPS Return Label. Identify and isolate all affected products in your inventory. Complete the response form and return it with any affected product to the address above using the return label. Upon return of the affected product, the manufacturer will ship replacement products to your facility at no charge. If you have distributed any of these products to customers or other locations, please provide JT Posey, by post or fax, with the name, address, telephone number, contact name, date of purchase, quantity and model number of products purchased by each consumer. For more information, contact your local representative or directly with the manufacturer at jlidikay@posey.com.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Some electrodes in the above stimulation kits are not attached to a connector. the manufacturer commenced removal by letter dated january 16, 2001.
Acción
Check receipt of the letter dated January 16, 2001 from Medtronic. Identify and isolate all affected products in your inventory. The manufacturer states that all products that were not implanted were recovered and that all physicians who implanted the stimulators were notified. ECRI recommends that you determine if any of the above units have been deployed in your institution and by whom. Enter the name of the doctor who implanted the product that was removed. The implantologist must decide whether a medical intervention is necessary in patients who have already undergone the implant. Medtronic does not recommend withdrawal of an already implanted product. She states that the error can be controlled and does not recommend implant removal or re-intervention. For more information, contact your local representative or directly with Medtronic at 1 (612) 514-5000 in the United States. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Some of the tubes above did not have the required amount of lithium heparin. the distributor started the removal by letter dated august 17, 2001.
Acción
Check out BD Vacutainer Systems has already contacted you. Identify and isolate all affected products in your inventory. For more information, contact your local representative or directly with BD Vacutainer Systems at (888) 237-2762 in the United States. ANVISA is interested in following if there was good collaboration of the distributor with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above analyzers give incorrect and low results for a number of patient samples. the distributor started the removal by letter dated april 9, 2001.
Acción
Check receipt of the letter dated 9 April 2001 from Dade Behring. The company claims that it provided consumers with updated Dimension RxL software with version 5.1.1 on April 17, 2001. For more information, contact your local representative. ANVISA is interested in following if there was good collaboration of the distributor with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Causa
At elevated temperatures, the above analyzers may exhibit a variation in haematological results due to a failure of the 486 microprocessor chip. the manufacturer initiated the removal by telephone on august 30, 2000 and by letter dated september 7, 2000.
Acción
Check your phone receipt on August 30, 2000 and / or the letter dated September 7, 2000 from Abbott Laboratories. Discontinue use of the above product and use another method to report haematological results until an Abbott representative can visit your facility. If your Model 3200 CS or Model 3200 SL CELL-DYN analyzer has been installed, a local Abbott representative must have checked your drive and replaced the defective 486 microprocessor chip with a good 486 microprocessor chip. If you are a new customer of CELL-DYN and your analyzer has not been installed, your local Abbott representative will inspect and replace any defective 486 microprocessor chips during installation in your unit. For more information, please contact your local representative.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above software has a partially activated false-thromboplastin time period. the manufacturer initiated the correction by a letter dated 25 june 2001 from dade behring.
Acción
Check receipt of letter dated June 25, 2001 from Dade Behring. The company claims that representatives have updated customer data files. For more information, please contact your local representative. ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The clinical scientific literature and the databases of technovigilance contain numerous reports of injuries in magnetic resonance centers (mri) and some reports of deaths. ecri states that most of the incidents are caused by interactions of the electromagnetic fields of magnetic resonance systems and other equipment in or brought into the mr environment, and that these incidents can be attributed to one of the following phenomena: forces static magnetic field, radio frequency heating, image artifacts and malfunctions. because of the existence of a static magnetic field of the mr system, iron and other magnetic materials are subject to two different forces: torque and translational force. ecri suggests that for magnetic and magnetic iron implants, torque can lead to compression or torsion of the tissues underlying the implant, which may cause rupture of the blood vessels and may cause changes in the orientation of the magnetic particles implanted in the patient. translational forces can cause magnetic or other ferromagnetic objects that are not fixed, to launch and literally fly through the air; this phenomenon is called a projectile effect. even appliances that may look safe, have become projectiles in the rm environment (eg some pillows and sandbags, which contain magnetic iron components). another potential consequence of a projectile incident is that it can cause superconductive system drop. ecri says that the radio frequency electromagnetic field of the rm system can induce currents in present, electrically conductive materials within the nucleus, bore¿ of the mr system. the induced current in counterpart can cause heating of the conductor, which can lead to burn of the patient if the conductor is in contact with the body. patients may serve as a whole or part of conductive circle, and have received burns where their toes or hands touched the thigh on the same side or on the bridge where their thighs were touched or crossed their arms. also, rare reports suggest that patients with tattoos have suffered mild localized heating burns, since tattoos may contain iron oxide or other magnetic iron substances, which are conductive. other problems that have been reported are image artifacts that may result in field disturbance, by signals sent by conductive materials in the mr environment, and by radio frequency disturbance. because they affect image quality, image artifacts can also affect the diagnostic value. finally, the static magnetic field of the rm system and its radio frequency and its magnetic gradient fields can seriously affect the operation, reliability, and accuracy of medical products that were not designed or designed appropriately for the mr environment. monitor alarm should alert rm personnel to magnetic disturbances.
Acción
ECRI recommends the following to ensure the safe use of the equipment in the RM environment: (1) designate a safety officer to ensure that the procedures are effective and consistent for the safety of the RM environment. (2) Establish and periodically review procedures and MRI routines and evaluate the level of compliance by your staff. (3) Identify areas of the RM room and adjacent areas on other floors where the magnetic force exerts an influence greater than 5G. Set this area as the RM environment and restrict access to this area. (4) Give formal training on safety considerations in the RM environment for all RM personnel and for all other personnel who may enter the RM environment. (5) Carefully inspect all persons entering the RM environment for presence of magnetic or conductive objects, inside, on or in conjunction with their bodies. (6) Check patients' medical records carefully about implants or other suspicious foreign objects. (7) If possible, only allow access to the MR environment, to patients wearing hospital gowns without traces of metallic gum. (8) Do not allow any equipment or product containing magnetic components (especially ferromagnetic) above critical level 5G unless they are labeled, safe or compatible with the RM environment. In addition, make sure that you are following the manufacturer's instructions regarding the compatibility of the products with the safety in the RM environment. (9) Keep the list of safe and compatible equipment and products in a conspicuous location, including restrictions on use. (10) Do not change safe or compatible equipment. (11) Be extremely careful if you must use equipment with ferromagnetic components in the RM environment; To prevent these equipment from moving too close to the RM system, the equipment must be properly labeled and must be at a safe distance from the RM system secured / retained by non-magnetic means. (12) If possible, use fiber optic, carbon fiber, graphite or high impedance electrodes instead of conductive or low impedance electrodes, wide-area electrocardiogram electrodes. (13) Remove all unused or unnecessary materials that are electrically conductive (eg, electrodes, sensors, cables, RF guides) from the patient and from the proximity of the cylinder. If electrically conductive conductive materials should remain in the cylinder, be sure to prevent this material from contacting the patient. (14) Give the patient a compatible, safe alarm with MRI so that it alerts the staff in case of an emergency. (15) Do not assume that objects such as sandbags or hospital pillows are safe in the RM environment without testing them. (16) At least, equips the room with safe oxygen equipment for the RM environment.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
A component located inside the junction box attached to the feet of the above beds may fail and, in very rare cases, may cause the junction box to overheat. the manufacturer commenced the correction with a letter dated august 31, 2001.
Acción
Verify receipt of the letter dated August 31, 2001 from Invacare. Identify and isolate all products in your inventory. If your facility has not been contacted, please contact your vendor for details on how to order the new components and install them. For more information, contact your local representative or directly with Invacare at 1 (440) 329-6000 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The methadone concentrations of the above kits were manufactured at methadone concentrations below the target value. this may result in out-of-range control values inserted into the kit when tested with adx, tdx / tdxflx or axsym methadone reagents. the manufacturer states that no other analyzer in the above kits has been affected.
Acción
Please verify receipt of the product recall letter dated June 14, 2001 from Abbott Laboratories. Identify and isolate all affected products in your inventory. Please retain and attach the product correction letter including Annexes I and II describing the new limits for batches of the above methadone components for your laboratory records. Reestablish the limits of variation of laboratory controls for the above methadone components based on the charts provided in the charts sent by Abbott Laboratories. If you have shipped this product to other laboratories, Abbott requests that you inform the units of this removal. For more information, please contact your local representative. ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
A defect reported in the above information systems may result in incorrect data being filed in the patient file / dossier. the manufacturer has initiated the correction by product safety note number psn-01-l11, dated april 10, 2001.
Acción
Please verify receipt of Product Safety Notice number PSN-01-L11 dated April 10, 2001 from Sunquest Information Systems. If the product is in use, follow the established temporary procedures described in the Sunquest Information Systems note. Product repair can be obtained by contacting your local representative or directly with Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact Sunquest Information Systems at 1 (520) 382-6170. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
A defect reported above in the laboratory information systems may result in incomplete reporting. the manufacturer has initiated the correction by product safety note number psn-01-l12 dated april 19, may 16 and 23, 2001.
Acción
Please verify receipt of Product Safety Note number PSN-01-L12 dated April 19, May 16 and 23, 2001 from Sunquest Information Systems. If the product is being used, follow the procedures outlined in the note from Sunquest Information Systems. Product repair can be obtained by contacting your local representative or directly with Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact Sunquest Information Systems at 1 (520) 382-6170 in the United States. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
A defect reported in the above information systems may cause lab test results to be printed incorrectly. the manufacturer initiated the correction by product safety note numbers psn-01-l08 and cn-01-07 dated march 23 and april 16, 2001 respectively.
Acción
Please verify receipt of Product Safety Note numbers PSN-01-L08 and CN-01-07 dated March 23 and April 16, 2001, respectively, submitted by Sunquest Information Systems. If the product is being used, follow the temporary procedures set out in the above-described Product Safety Note number CN-01-07, submitted by Sunquest Information Systems. Product repair can be obtained by contacting Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact your local representative or Sunquest Information Systems at 1 (520) 382-6170 in the United States. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Ecri has received reports of leaks and spills of anoxic cryogen that resulted in death by asphyxia of 2 experienced users. the 2 most used cryogen, liquid helium and liquid nitrogen, are anoxic, so there are risks of suffocation when a certain amount of them is introduced in small or poorly ventilated places. because they are painless and colorless, they are not detectable in their gaseous form, and fatal accidents can occur in the absence of the use of specialized protective equipment. anyone who enters an area filled with one of these two gases without the use of safety equipment will be quickly rendered impossible. signs of asphyxiation are an increase in respiration and heart rate, dizziness, nausea, loss of consciousness leading to loss of consciousness and death.
Acción
ECRI recommends the following: (1) alert users and any other specialized staff to the risks associated with cryogenics. (2) Verify that all safety precautions, procedures, and training are adequate and that they are performed. (3) Verify that O2 monitors are used in all enclosed places where anoxic cryo are handled and stored. (4) Ensure that respiratory protective equipment (breathing apparatus) is always available and make sure there is a means of preventing future leakage or if there is a suspected leak if there is a means to prevent them. (5) Check that all safety equipment is working and checked. (6) Verify that all employees know the procedure when a leak occurs. (7) Ensure that alert signs are readily visible in all places cryogenics are used daily. For more information, please contact your local representative or ANVISA Technovigilance Unit at 0xx61-4481485 or 448.1331 notifying any occurrences associated with these products by completing the Health Product Associated Notices Form available on the Internet - http://www.anvisa.gov.br/tecnovigilancia, sending it directly through the Internet or saving the completed file and sending via e-mail to tecnovigilância@anvisa.gov.br. If you prefer to print it and send it by fax 0xx61-4481257
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Ecri has received reports of leaks and spills of anoxic cryogen that resulted in death by asphyxia of 2 experienced users. the 2 most used cryogen, liquid helium and liquid nitrogen, are anoxic, so there are risks of suffocation when a certain amount of them is introduced in small or poorly ventilated places. because they are painless and colorless, they are not detectable in their gaseous form, and fatal accidents can occur in the absence of the use of specialized protective equipment. anyone who enters an area filled with one of these two gases without the use of safety equipment will be quickly rendered impossible. signs of asphyxiation are an increase in respiration and heart rate, dizziness, nausea, loss of consciousness leading to loss of consciousness and death.
Acción
ECRI recommends the following: (1) alert users and any other specialized staff to the risks associated with cryogenics. (2) Verify that all safety precautions, procedures, and training are adequate and that they are performed. (3) Verify that O2 monitors are used in all enclosed places where anoxic cryo are handled and stored. (4) Ensure that respiratory protective equipment (breathing apparatus) is always available and make sure there is a means of preventing future leakage or if there is a suspected leak if there is a means to prevent them. (5) Check that all safety equipment is working and checked. (6) Verify that all employees know the procedure when a leak occurs. (7) Ensure that alert signs are readily visible in all places cryogenics are used daily. For more information, please contact your local representative or ANVISA Technovigilance Unit at 0xx61-4481485 or 448.1331 notifying any occurrences associated with these products by completing the Health Product Associated Notices Form available on the Internet - http://www.anvisa.gov.br/tecnovigilancia, sending it directly through the Internet or saving the completed file and sending via e-mail to tecnovigilância@anvisa.gov.br. If you prefer to print it and send it by fax to 0xx61-4481257.