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
If you have any questions regarding this action, please contact Philips by phone: 0800 701 7789
Causa
Philips healthcare has discovered, by means of trend analysis, an increase in the error rate of certain low voltage dc ("facc") power supplies used in these products. each system contains multiple faccs, some of which may be subject to a high probability of error. failure of a facc may result in the sudden loss of image acquisition or mechanical motion functionality, depending on which subsystems the facc is feeding. the severity was classified as resulting in severe injury: life threatening or permanent damage or need medical intervention to avoid permanent damage. the probability of occurrence was classified as possible but unlikely. the conclusion of the risk analysis was not acceptable.
Acción
Field action FCO72200371 Sending letter to clients (attached) // FACC replacement affected.
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
Actions to be taken by the user: Roche Diagnóstica invites the users of the product involved to contact the company to request a new box, duly accompanied by instructions for use in Portuguese. The user should contact Roche Diagnóstica, through the telephone 0800-772-0295, forwarding a copy of the invoice of the product purchased between 07/01/2015 and 08/10/2016. Within 10 business days, the user will receive the new product. The company is also available to answer any queries, by calling 0800-772-0295, or e-mail brasil.vozdocliente@roche.com -xxxxxxxxxxxxxxxxxxxxx-xxxxxxxxxxxxx- If you wish to notify technical complaints and adverse events, please use the channels below: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link #### UPDATED ON 08/22/2017, the company sent a report of completion of the field action proving the sending and communication to customers regarding the misconception of the product shipment without the instructions for use.
Causa
The coaguchek xs pt test strips product, 6 units, code 04625374190, was supplied without the accompanying instructions for use in english.
Acción
Field Action No. RDB_2016_001 triggered under the responsibility of Roche Diagnóstica Brasil. Correction of Instructions for Use - Requires Alert Message on large circulation media.
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
Recommendation to Users and Patients: Siemens recommends users to place an additional external filter in the water circuit, which will implement a protection mechanism to prevent functional failure of the pump system as a result of contamination. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Possible cause of system defect due to contaminants in the form of biomass that can develop in the cooling system of the artis systems, resulting in damage to the pump system. the presence of contaminants in the tube cooling circuit impairs the performance of the pump. this failure may even lead to a functional failure of the system. the tube assembly may become superheated so that no radiation can be released.
Acción
Field Actions No. AX006 / 15 / S & AX007 / 15 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA deal with a correction in the field, correction of parts / pieces, by means of previous letter sending to the client.
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
(1). Customers should discontinue use immediately, and quarantine any available inventory products of batch numbers / product codes attached. (2). Distributors should stop immediately distributing any of the batch numbers / codes from the enclosure, quarantine any available inventory, and send this recall notice immediately to each customer who received these products to inform them of this problem. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Terumo medical of brazil is initiating this recall based on internal research and tests performed by the manufacturer which revealed that during final tests for the release of the misago® self-expanding peripheral stent, it was found that they did not conform to the specifications defined in regulatory submissions regarding the diameter of the stent at the proximal / distal ends after self-expansion and / or stent shape. the investigation has determined that the compression forces applied to the stent during its assembly in the release catheter can cause minimal deformation and / or overlap in the stent rods. this may result in reduced diameter at the ends of the stent during deposition due to incomplete expansion, or in deformation in the shape of the stent, such as bending or inconsistent alignment of the stent rods.
Acción
Field Action Code Recall Voluntary Self-expanding Misago Stent triggered under the responsibility of the company Terumo Medical do Brasil. Retrieval for further destruction.
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
For products marketed as of 7/31/2016, their commercialization and use should be suspended. The affected products must be segregated and returned to the manufacturer. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. ## UPDATE # Field action closure: 12/2/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized. UPDATED ON 08/16/2017. The reason for the notification was discontinuation of the manufacture of regularized product. This situation does not constitute a motivation for field action, under the terms of RDC No. 23/2012.
Causa
Commercialization of the product with its expired registration with anvisa. the product registration was not revalidated due to the discontinuation of its manufacture by ventura biomédica.
Acción
Field Action Code 194/2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing collection of products marketed from 07/31/2016.
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
Recommendations to Users and Patients: If you HAVE an alternative lot of Emerald Cleaner available in stock (except 6853, 6901, 6953, 6991, 7024 or 7027), immediately discontinue use of impacted lots of Emerald Cleaner. 1. Start using the alternative lot of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1 -3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Return the remaining stock of the impacted batches of Emerald Cleaner according to your laboratory procedures. If you do not have an alternative batch available and you are not observing QC outside the low range for RBC and PLT parameters, immediately request a replacement lot from Emerald Cleaner. Make sure you meet your internal QC requirements. You can continue to use the batch until the replenishment arrives. After you receive the replacement batch, follow steps 1-3: 1. Begin using the alternative batch of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1-3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Please return the remaining stock from lots 7044, 7082, 7110 or 7119 according to your laboratory procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Abbott has previously identified occurrences where the cell-dyn emerald analyzer generated out-of-range qc results for the rbc and plt parameters when using emerald cleaner lots 6853, 6901, 6953, 6991, 7024, and 7027 tests with lots 7044, 7082, 7110, and 7119 confirmed the out-of-range rbc and plt controls. the cause of the problem (qc material outside the low range) has been identified in the manufacturing process of a raw material used in the cell-dyn emerald cleaner.
Acción
Field Action FA24MAR2016 - Revision 02 triggered under the responsibility of Abbott Laboratories of Brazil. Gathering for Destruction
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
Recommendations to Users and Patients: Until software is updated, users should turn off and on affected devices monthly, especially if the user does not completely turn off the device when no patient is being monitored. Review this information with all team members who need to be aware of the content of this release. It is important to understand the implications of this release. A Philips Healthcare representative will contact customers with the affected devices to arrange for the software update installation. If you have any questions or concerns regarding this correction, please contact your local Philips dealer or our Philips Customer Service Center at 0800-701-7789. Service from Monday to Saturday from 07 to 19h. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
If an affected patient monitor has been held continuously for several months, all displayed waveforms will contain outdated data and therefore will not match the patient's current condition. even if outdated waveforms are displayed because of this problem, the alarms and numeric indicators of the monitor's vital signs will continue to function as specified and reflect the patient's current data accurately. the time interval during which a monitor must remain connected before displaying the problem depends on the speed of the selected wave. it ranges from 102 days (at 50 mm / s) to 820 days (at 6.25 mm / s), and is approximately 205 days at the standard 25 mm / s wave velocity of the monitor. the monitor should be turned off to avoid this problem. just putting it into standby mode is not enough.
Acción
Field Action FCO86201725 triggered under the responsibility of the company Philips Medical Systems Ltda. Field Correction by updating the Software for the affected Philips IntelliVue Patient Monitors.
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
Action required for laboratories that have the affected lot: • VITROS TT4 Reagent Kits (listed above and future lots 2008 and later) should only be used within 4 weeks of opening. Manually track the time interval for storing the reagent kits opened for Batches prior to 2008. • The VITROS TT4 Instructions for Use (IFU) will be updated to reflect this change. The revised Instructions for Use (IFU) will be available on our website at http://www.orthoclinical.com, when the next batch is released, which is expected to begin in June 2016. In the meantime, please keep this notification to checking the change in the storage requirement of open reagent kits. • In accordance with regulatory requirements, complete and return the Receipt Confirmation. • This is a situation in which the use of the product is not likely to cause adverse health consequences. • Incorrect value may cause undue results. The Laboratory Medical Officer should be consulted about any questions you may have regarding previously reported TT4 results to determine the appropriate course of action. The results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
This notification informs that the batches identified above have been approved and met the release test specifications prior to release. however, further testing indicated that the sample results, generated using the vitros tt4 reagent kits that were open more than 4 weeks ago, may demonstrate a negative bias.
Acción
Field Action No. 16000094 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda.
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
The company emphasizes that there is no need for additional recommendations beyond those contained in the Instructions for Use of the product once the technical, manufacturing and validity characteristics of the product have been maintained. The measure taken by the company was the immediate blocking of sales and recall of the product as soon as it was found that the registration of the product had expired. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
The company missed the deadline for revalidation of registered product registration under the number 10175060023. therefore, it decided to include the product "accessories for liquor system" (record 10175060023) in the product register "synchrony-cello series hydrocephalus valve" anvisa 10175060021), whose process has not yet been approved by anvisa (protocol 25352876203201622).
Acción
Field Action No. 186/16 triggered under the responsibility of Ventura Biomédica Ltda. Company is promoting the recall of the products that are in the market.
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
The product must be segregated and returned to FRESENIUS HEMOCARE BRASIL LTDA
Causa
The company received an account from a blood bank about some medical complications related to the transfusion procedure with a patient.
Acción
Field Action Code RA 03-2016 triggered under the responsibility of the company FRESENIUS HEMOCARE BRASIL LTDA. Company is performing product recall.
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
The customer letter describes the actions that Olympus is taking for this field action and informs the customer that the equipment can be used normally in the meantime. It also informs customers that they will continue to follow current reprocessing and cleaning guidelines until they receive new versions of manuals. Warning: SEE ALSO TECNOVIGILANCE NO. 1829 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through System NOTIVISA. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Olympus received customer complaints for the tjf-160vf and tjf-160f duodenoscopes associated with infections in patients after performing endoscopic procedures. olympus decided to increase the safety margin for the tjf-160vf and tjf-160f. root causes for the problem: the exact causes have not been conclusively determined in many cases (infections can be caused by factors such as inappropriate use of automated endoscope scanners or disinfectants, inappropriate handling of reprocessed devices, etc.). improper reprocessing by users can not be excluded in some cases. no problems were found in the manufacturing process of the tjf-160vf and tjf-160f.
Acción
Field Action Nº FA_148_04 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company is performing Safety Alert and providing brushes to optimize product cleaning.
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
The consequences that may occur with the use of outdated software are: incorrect designation of the isocenter when using multiple treatment plans with different isocenters based on a single planning TC and when a CBCT is acquired for each isocenter and irrevocable designation of the first 2D image of reference. Recommendation to users and patients: Include the Field Action Letter along with the System Owner's Manual. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Siemens healthcare diagnósticos sa informs that the th006 / 16 / s field action is the version of the syngo rt oncologist tm software running 4.3.Sp1 or 4.3.138 or 4.3.1_mr2.
Acción
Field Action No. TH004 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA The company is carrying out a software update.
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
The company informs you to check the inventory, discard any inventory from the remaining lot, and contact Internal Sales or your local distributor if replacement is required.
Causa
According to the company, a technical investigation has confirmed that thermo scientific ™ oxoid ™ ct1629b caz10 ceftazidime, batch 1426486 may contain discs with a reduced concentration of antibiotic that may impact performance. tests with pseudomonas aeruginosa atcc 27853 (eucast quality control body) returned smaller than specified inoculation zones.
Acción
Company will collect products, while recommending stock verification, discard any remaining lot inventory and replacement request (FSCCT1629B - lot 1426486).
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
The company informs that: • Before receiving the revised Instructions for Use (IFU), be aware that positive deviation results may occur for patients taking Fulvestrant. Follow your normal laboratory procedures, as you would for other known sample interferences. Note: It is acceptable to continue using VITROS Reagent Kits for Estradiol. • Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action. • Place this notification on your VITROS System or along with your user documentation.
Causa
Ortho clinical diagnostics (ortho) has been aware of the potential for drugs, which are derived from estrogen (eg fulvestrant, trade name: faslodex®), in interfering with estradiol immunoassays and causing positive deviation results. because of this problem, we are initiating this urgent product fix.
Acción
1. Type of Field Action: Updating, correcting or supplementing the instructions for use. 2. Field Action Code: 16000112 3. Recommendations to Users and Patients: According to the company, Ortho's research confirmed results of Estradiol with positive deviation in samples obtained from postmenopausal women containing 30 ng / mL of Fulvestrant (peak serum concentration of this therapeutic drug). Events that may have occurred prior to this communication are not easy to identify without knowledge of Fulvestrant administration for each patient; thus a review of past results may not be possible. Consider the need to notify your physicians / clinicians about oestradiol results for women who have received Fulvestrant. Talk to your Lab Medical Director about any questions you may have regarding previously reported results for estradiol to determine the appropriate course of action. The results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture.
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
ATTENTION: The precautions described in the Astral labeling and in the safety warning issued by the company must be obeyed. SERVICE REQUIREMENTS: Astral batteries should be inspected regularly according to the User Manual. The ResMed or ResMed Authorized Service Center will also check the internal battery performance performance and software updates. Customers with equipment approaching the two-year maintenance cycle should contact an Authorized Service Center to arrange maintenance service.
Causa
When astral fans are used with the internal battery as their only electrical source, it is important to note that internal battery failure can lead to interruption of treatment without "battery low" or "critically poor battery" alarms even firing battery is charged. in such cases, ventilator-dependent patients (patients unable to maintain adequate ventilation without assistance and deteriorating conditions) may be at risk if no urgent action is taken to restore energy or to initiate an alternative form of ventilation. resmed received a small number of reports (<0.1% of handsets sold globally) of a performance problem associated with the astral 100 and 150's internal batteries. although these events are extremely rare, it is important that you follow the important ones you follow the precautions described in the astral labeling and this fsn.
Acción
Field Action code 9 triggered under the responsibility of the company MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company issued Safety Alert with precautions to be taken by users, caregivers and health care workers Precautions to be taken by users / caregivers in the home or health / hospital environment 1.Connect the ventilator to electrical power via alternating current whenever possible. In the event of a battery failure, connect the device to the AC source immediately to resume ventilation. 2. If possible, use an external power source (external Astral battery or RPSII battery) for ventilation dependent patients. 3. If possible, use an external power source (Astral external battery or RPSII battery) in mobile situations, including when AC power is unavailable or is interrupted. Do not rely solely on the internal battery for mobile use. 4. Ensure that the external battery source is sufficiently charged before using the equipment in mobile situations. 5. When treating ventilator-dependent patients, always have alternative ventilation equipment available, such as a back-up ventilator, manual resuscitator, or similar device. 6. Ventilation dependent patients should be continuously monitored by qualified personnel or appropriately trained caregivers. Such persons and caregivers should be able to take corrective action in the event of a malfunction of the ventilator alarm. 7. Follow Astral's maintenance service plan every two years. At this point, the internal battery will be replaced. 8.Equipments with batteries approaching two years of use and with frequent battery depletion should be monitored for battery performance verification in accordance with the operating instructions, including a periodic check that the battery has adequate charge capacity. Batteries that have reduced performance performance should be replaced immediately. 9. Return the equipment to a Service Center if it presents any reports of battery problems or significant degradation of battery performance.
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
Recommendations: 1. Segregate products in stock; If you wish to notify technical complaints and adverse events, please use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should be sent to the manufacturer for later disposal (de-characterization / destruction) made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link ## UPDATE ## Field Action Closing: 12/12/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized.
Causa
During inspection by entities of the national system of sanitary surveillance (snvs) it was evidenced that the company was manufacturing and marketing product in disagreement with the specifications of the project and in disagreement with its registration with anvisa.
Acción
Field action 204/2016 triggered under the responsibility of Ventura Biomédica Ltda. - CNPJ: 57.182.230 / 0001-36, which involved the immediate stoppage of the manufacturing and marketing of the product; communication to customers for blocking commercialization and use, recollection for later destruction / decharacterization.
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
Philips plans to replace the system's power supply unit of the Compano Basic PCR scanner, which will eliminate this problem. A Philips Maintenance Engineer will contact you as soon as the Action Kit is available to be implemented. /// If you need to communicate with Philips about this program, please refer to Amendment Request 73200037./// If you need more information or support for this issue, please contact our Philips Solution Center through telephone 0800-701-7789. Service from Monday to Saturday from 07h to 19h.
Causa
A faulty component of the compano reader's power supply may cause the power supply to burn and produce smoke in the compartment.
Acción
Field classification: Field correction by replacing the power supply unit of the PCR reader system Basic affected /// Field action code: FCO73200037 /// Recommendations to users and patients: The system can be used in accordance with the Instructions for Use without restrictions. In case of fire, the user may alert the fire department, use an extinguisher and / or evacuate the premises.
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
The BD recommends that the lab verify the current BD Phoenix System settings to ensure that the default configuration has not been modified. If the rules specified in the letter sent to users are disabled, BD recommends that the default setting be restored.
Causa
The company states that "a new strain isolate of klebisiella pneumonia has been identified. the new isolate presents a change in the susceptibility test to cefepime present in phoenix gram negative panels. the new isolate may give a false susceptible result. after investigation with several strains of this microorganism it was concluded that the phoenix system and the panels continue to perform as expected and that the possible change in the susceptibility test occurs as a function of the change of the microorganism.
Acción
The company informs that the data of the BD Phoenix Gram negative panels are performing as expected, as there was a change in the strain of the microorganism. Therefore these Products are not under risk. Also regarding the possibility of release of false susceptible result, the Phoenix BD System has features that automatically correct the result or send alert message to the health professional of the Laboratory. Assuming that a false susceptible result is released, the risk is associated with inappropriate antibiotic use.
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
Recommendations to users and patients: The manufacturer requested the collection of the lot and the proper segregation of the units collected. After the recall, the manufacturer requests that all units be sent to Lemaitre. Regarding the products that were already used, the manufacturer did not request any further action.
Causa
The company clarifies that on 05/08/2016, an official recall statement was received from the manufacturer lemaitre vascular inc, of the product valvulootro hydro longo lemaitre, model 1009-00, lot elvh1082v, of which 5 units were sent to brazil and received on 06/23/2016, according to nf 60436. such collection is due to reported failure to close hoops at the moment of the drive. in some cases, this problem was discovered during use. although there are no reports of adverse events, there is a possibility that a malfunction of the device could damage the vessel at the time of withdrawal. the manufacturer requested the collection of the lot and the proper segregation of the collected units. after the recall, the manufacturer requests that all units be sent to lemaitre. regarding the products that were already used, the manufacturer did not request any further action.
Acción
Field Action No. CWB21 triggered under the responsibility of Tecmedic Comércio de Produtos Médicos Ltda. Risk classification: III (Risk of serious adverse event occurrence) Classification of the field action: Recollection; Return to the manufacturer.
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
Discontinue use, segregate affected products and return them to the manufacturer. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link ## UPDATE # Field action closure: 12/12/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized.
Causa
Product outside the design specifications and in disagreement with the anvisa registration. ventura biomédica included a clamp, which is in disagreement with the project of the product and with its registration with anvisa.
Acción
Field Action Code 205/2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing recall of the affected products.
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
For products marketed from 08/14/2016, their commercialization and use should be suspended. The affected products must be segregated and returned to the manufacturer. ## UPDATE # Field action closure: 12/2/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized.
Causa
Commercialization of the product with its expired registration with anvisa. the product registration was not revalidated due to the discontinuation of its manufacture by ventura biomédica.
Acción
Field Action Code FNC 195-2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing collection of products marketed from 08/14/2016.
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
Suspend the marketing and use of the product. Products remaining on the market should be segregated and returned to the manufacturer. ## UPDATE # Field action closure: 12/12/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized. ### UPDATED ON 8/16/2017. The reason for the notification was discontinuation of the manufacture of regularized product. This situation does not constitute a motivation for field action, under the terms of RDC No. 23/2012.
Causa
Cancellation of the registration of the product with anvisa, since ventura biomédica chose to discontinue its manufacture.
Acción
Field Action Code FNC 216-2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing collection of the remaining products on the market.
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
Non-deployed product units should be segregated and returned to the manufacturer.
Causa
Non-compliant product lot has been released to the market.
Acción
Field Action No. 130Q triggered under the responsibility of the company MDT Indústria e Comércio Importation and Exportation of Implants S / A. Company is promoting the product collection Interchangeable Head of Inox - Register 10417940036.
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
s non-deployed product units shall be segregated and returned to the manufacturer.
Causa
Absence of proximal curvature specified in the technical drawing.
Acción
Field Action Nº RR 120Q triggered under the responsibility of the company MDT Indústria e Comércio Importation and Exportation of Implants S / A. Company is promoting the product collection Tube Plate - Registration 10417940029.
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
Non-deployed products should be segregated and returned to the company that holds the record.
Causa
Product manufactured and marketed in disagreement with specifications.
Acción
Field Action No. R2015077 triggered under the responsibility of JOHNSON & JOHNSON; OF BRAZIL. Company is performing recall for psoterior destruction of the affected products.