French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot PSR1 of the reagent called OPUS PSA Modules test - reference OWZT (prostate specific antigen assay) of the company DADE BEHRING SA is withdrawn from the market due to a background noise that is too high that could lead to a failure of the calibration.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Batches 730643001 (expiry date 11.06.2001), 735480101 (expiry date 17.08.2001), 737735301 (expiry date 03.11.2001), 739475801 (expiry date 30.12.2001) of the reagent called HDL Cholesterol / Phospholipids - reference 61531 from the company BIOMÉRIEUX SA are withdrawn of the market following a decrease in the HDL cholesterol level of the calibrator present in the kit.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
The batch 737021301 (06/04/2001 expiry) of the reagent called CHOLESTEROL CALIBRATOR - reference 62473 of the Company BIOMERIEUX SA is withdrawn from the market, because of the reduction of the cholesterol level of the calibrator, without clinically significant incidence on the patients' results .
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 negative control dilute / sample of the kits of tests mentioned, indicate false-positive results. the manufacturer started a removal by correspondence, phone and fax on july 20, 2000.
Acción
MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS DECLARES THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF YOUR LOCAL MERIDIAN DIAGNOSTICS 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 negative control dilute / sample of the kits of tests mentioned, indicate false-positive results. the manufacturer started a removal by correspondence, phone and fax on july 20, 2000.
Acción
MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS DECLARES THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF YOUR LOCAL MERIDIAN DIAGNOSTICS 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
Rings used in the diaphragm mechanism were inadvertely molded with the wrong nucleus pin, which could result in the leakage of the expiration valve if processed and remote. the manufacturer started a removal by correspondence dated 24 july 2000.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE DATED CHECK OF 24 JULY 2000 FROM INSTRUMENTATION INDUSTRIES. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR PRODUCT REPLACEMENT OR FOR FURTHER INFORMATION, CONTACT YOUR INSTRUMENTATION INDUSTRIES REPRESENTATIVE
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lots 810013002 (per.08.12.2000), 819263002 (per.15.08.2000), 810094002 (per.28.02.2001) of the reagent called Stratus CS MYO DILPAK - code CMYO-D 840073002 (per.13.03.2001), 840151002 (per30.05.2001) the reagent called Stratus CS CKMB DILPAK- code CCKMB-D; 830073002 (per.13.03.2001), 830115002 (per.02.04.2001), 830151002 (per.28.11.2000) of the reagent called Stratus CS TROP DILPAK- code CCTNI-D of the company DADE BEHRING SA are withdrawn from the market following a problem with the Stratus CS analyzer version 1.2.1 software when rendering the results for the automatically diluted heparin plasma samples. As a precaution, to avoid the possibility of erroneous results, was decided to block the automatic dilution function by removing the dilution reagent dedicated to this analyzer.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
The batch 742181901 (expiry 17.10.2000) of the reagent called TPHA Kit - reference 72491 of the company BIOMERIEUX SA is withdrawn from the market following the appearance of a retracted agglutination veil with certain serum samples that may hinder the reading.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 90 (per 15.09.2000) of the reagent called Vitros Immunodiagnostic Products / prolactin reagent cartridge (reference 1849793) and batch 90 (per 15.09.2000) of the associated reagent called Vitros immunodiagnostic Products / prolactin standards (reference 1113596) of ORTHO-CLINICAL DIAGNOSTICS are withdrawn from the market due to the possibility of calibration failure.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot BN1054 (expiry date 23.02.2001) of the reagent called DIMENSION DIGOXINE (DGNA) - code DF35A, from the company DADE BEHRING SA is withdrawn from the market, following possible erroneous results obtained occasionally, during the determination of digoxin.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
The batch OE146R (péremption15 / 05/2001) of the reagent called disks of CEFTAZIDIME 30mcg (code 66308) of the company BIO-RAD is withdrawn from the market, some cartridges of the batch containing 50 disks not impregnated with ceftazidime (risk of rendering results of false resistance to ceftazidime).
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
In case of malfunctioning of the operational amplifier used in the skin temperature measurement circuit, the epithelial temperature probe of the above neonated incubators may super heat. draeger medical declares that excessive heating of the modeloo 8000 incubator probe results, as reported, in burns in a newborn in the united kingdom. draeger medical declares that the same electrical configuration is used in the modeloo rh600 radiant heater. the distributor started a correction by correspondence dated 2 july and 28 august 2000.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCES DATED 2 JULY AND 28 AUGUST 2000 AND THE DRAEGER MEDICAL RESPONSE CARD. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DRAEGER MEDICAL RECOMMENDS TO TAKE THE FOLLOWING MEASURES: (1) DO NOT USE THE EPITHELIAL TEMPERATURE SENSORS CONNECTED DIRECTLY WITH THE DRAEGER MODELOO 8000 INCUBATOR OR WITH THE MODELOO RH600 RADIANT HEATER. (2) USE THIS EQUIPMENT ONLY IN ENVIRONMENTAL TEMPERATURE CONTROL MODE. (3) USE A SEPARATE TEMPERATURE MONITOR, IF NECESSARY. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO 8000 INCUBATOR UPGRADE OPTIONS: (1) REQUEST A DRAEGER MEDICAL UPDATE KIT. SEND THE FRAME OF FORMER PRINTED CIRCUITS (PCB) TO DRAEGER MEDICAL BY MAIL IN THE ADDRESS AFFECTED. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (2) IF THERE IS NO TIME AVAILABLE FOR EXCHANGE OF THE PCB, THE COMPLETE ELECTRONIC CONTROL MODULE CAN BE REMOVED AND SHIPPED TO DRAEGERSERVICE. DRAEGER MEDICAL DECLARES THAT IT WILL MAKE A COMPLETE PCB EXCHANGE AND A FREE PREVENTIVE MAINTENANCE. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (3) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT DOES NOT HAVE AN AUTHORIZED DRAEGER MEDICAL TECHNICIAN OR HAS NO TIME TO PERFORM OPTIONS 1 AND 2, DRAEGER MEDICAL DECLARES THAT A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SERVICE WILL MAKE THE UPDATE ON THE SITE. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO RH600 HEATER UPGRADE OPTIONS: (1) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT MAY PARTICIPATE IN THE UPDATE, DRAEGER MEDICAL AFFIRMS THAT THE HEATER MUST BE SUBMITTED FOR PROPER CHANGE. THE HEATER WILL BE RETURNED UPDATED AND WITH FREE PREVENTIVE MAINTENANCE WITHIN THE 2 DAYS USEFUL DEADLINE. THE BIOMEDICAL ENGINEERING PERSONNEL MAY THEN REINSTALL THE HEATER AND FILL IN THE FEEDBACK FORM. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. (2) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT CAN NOT PARTICIPATE IN THE UPDATE, SEND THE HEATER TO DRAEGER MEDICAL, WHICH WILL MAKE A COMPLETE UPDATE. A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SUPPORT SERVICE WILL VISIT YOUR HOSPITAL TO INSTALL THE UPDATED HEATER. PREVENTIVE MAINTENANCE WILL BE MADE FREE OF CHARGE. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. FILL IN AND SEND THE CONFIRMATION RESPONSE CARD TO THE MEDICAL DRAEGER BY MAIL AT THE ADDRESS AFFECTED. FOR FURTHER INFORMATION REGARDING CORRECTION CORRESPONDENCE, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH JAMES BRENNAN, DRAEGER MEDICAL, BY MAIL AT THE ADDRESS OR AT TELEPHONE 1 (215) 721-5400, RAMAL 2363, IN THE UNITED STATES. FOR FURTHER INFORMATION REGARDING THE USE OF THE AFFECTED PRODUCTS, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH HARALD KNEUER, DRAEGERSERVICE, TELEPHONE 1 (215) 721-5400 RAMAL 6917, 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
In case of malfunctioning of the operational amplifier used in the skin temperature measurement circuit, the epithelial temperature probe of the above neonated incubators may super heat. draeger medical declares that excessive heating of the modeloo 8000 incubator probe results, as reported, in burns in a newborn in the united kingdom. draeger medical declares that the same electrical configuration is used in the modeloo rh600 radiant heater. the distributor started a correction by correspondence dated 2 july and 28 august 2000.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCES DATED 2 JULY AND 28 AUGUST 2000 AND THE DRAEGER MEDICAL RESPONSE CARD. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DRAEGER MEDICAL RECOMMENDS TO TAKE THE FOLLOWING MEASURES: (1) DO NOT USE THE EPITHELIAL TEMPERATURE SENSORS CONNECTED DIRECTLY WITH THE DRAEGER MODELOO 8000 INCUBATOR OR WITH THE MODELOO RH600 RADIANT HEATER. (2) USE THIS EQUIPMENT ONLY IN ENVIRONMENTAL TEMPERATURE CONTROL MODE. (3) USE A SEPARATE TEMPERATURE MONITOR, IF NECESSARY. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO 8000 INCUBATOR UPGRADE OPTIONS: (1) REQUEST A DRAEGER MEDICAL UPDATE KIT. SEND THE FRAME OF FORMER PRINTED CIRCUITS (PCB) TO DRAEGER MEDICAL BY MAIL IN THE ADDRESS AFFECTED. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (2) IF THERE IS NO TIME AVAILABLE FOR EXCHANGE OF THE PCB, THE COMPLETE ELECTRONIC CONTROL MODULE CAN BE REMOVED AND SHIPPED TO DRAEGERSERVICE. DRAEGER MEDICAL DECLARES THAT IT WILL MAKE A COMPLETE PCB EXCHANGE AND A FREE PREVENTIVE MAINTENANCE. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (3) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT DOES NOT HAVE AN AUTHORIZED DRAEGER MEDICAL TECHNICIAN OR HAS NO TIME TO PERFORM OPTIONS 1 AND 2, DRAEGER MEDICAL DECLARES THAT A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SERVICE WILL MAKE THE UPDATE ON THE SITE. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO RH600 HEATER UPGRADE OPTIONS: (1) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT MAY PARTICIPATE IN THE UPDATE, DRAEGER MEDICAL AFFIRMS THAT THE HEATER MUST BE SUBMITTED FOR PROPER CHANGE. THE HEATER WILL BE RETURNED UPDATED AND WITH FREE PREVENTIVE MAINTENANCE WITHIN THE 2 DAYS USEFUL DEADLINE. THE BIOMEDICAL ENGINEERING PERSONNEL MAY THEN REINSTALL THE HEATER AND FILL IN THE FEEDBACK FORM. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. (2) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT CAN NOT PARTICIPATE IN THE UPDATE, SEND THE HEATER TO DRAEGER MEDICAL, WHICH WILL MAKE A COMPLETE UPDATE. A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SUPPORT SERVICE WILL VISIT YOUR HOSPITAL TO INSTALL THE UPDATED HEATER. PREVENTIVE MAINTENANCE WILL BE MADE FREE OF CHARGE. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. FILL IN AND SEND THE CONFIRMATION RESPONSE CARD TO THE MEDICAL DRAEGER BY MAIL AT THE ADDRESS AFFECTED. FOR FURTHER INFORMATION REGARDING CORRECTION CORRESPONDENCE, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH JAMES BRENNAN, DRAEGER MEDICAL, BY MAIL AT THE ADDRESS OR AT TELEPHONE 1 (215) 721-5400, RAMAL 2363, IN THE UNITED STATES. FOR FURTHER INFORMATION REGARDING THE USE OF THE AFFECTED PRODUCTS, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH HARALD KNEUER, DRAEGERSERVICE, TELEPHONE 1 (215) 721-5400 RAMAL 6917, 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
An ecri member hospital reported an incident in which a physiological monitor interfered on the wav potential evocado of an evolved electromiography / potential equipment (emg / ep).
Acción
TO REDUCE THE EMISSION OF ELECTROMAGNETIC INTERFERENCE, EMI, AND MINIMIZE THE EFFECTS OF EMISSIONS IN HOSPITAL EQUIPMENT, ECRI RECOMMENDS THAT THE FOLLOWING: (1) MAKE SURE THAT APPROPRIATE FILTER ASSEMBLIES ARE SELECTED FOR SENSITIVE RECORDING EQUIPMENT. (2) REMOVE SENSITIVE EQUIPMENT FROM THE NEARBY OF OTHER ELECTRONIC EQUIPMENT, WHEREVER IT IS POSSIBLE. (3) USE DIFFERENT EQUIPMENT, IF NECESSARY. ECRI RECOMMENDS THE ADOPTION OF THE FOLLOWING PROCEDURES IN EQUIPMENT WITH ELECTRODES, CONDUCTOR WIREs AND CABLES FOR MINIMIZING EMI EMISSIONS: (1) ENSURE THAT GOOD QUALITY ELECTRODES ARE USED AND THAT ARE PROPERLY POSTED TO THE PATIENT. (2) IF STIMULATION AND RECORDING ELECTRODES ARE USED SIMULTANEOUSLY, SEPARATE THE TWO TYPES OF ELECTRODES TO THE MAXIMUM POSSIBLE. (3) KEEP THE DRIVING WIRES ORIGINATED FROM A SINGLE SOURCE, WHETHER AN INDIVIDUAL EQUIPMENT, AS AN EMG, OR A COMPOUND, AS THE MONITORING MODULE, GROUPED TO THE LARGE EXTENT POSSIBLE TO MINIMIZE MAGNETIC AND ELECTRICAL DISTURBANCES. (4) WHEN POSSIBLE, DIRECT THE ORIGINATED WIRES OF DIFFERENT SOURCES FOR DIFFERENT DIRECTIONS AND AVOID THE WIRING OF WIRES OF DIFFERENT EQUIPMENT. TO REDUCE EMI EMISSIONS FROM THE ENERGY SOURCE OF THE EQUIPMENT, ECRI RECOMMENDS TO TAKE THE FOLLOWING PRECAUTIONS: (1) CONNECT MEDICAL EQUIPMENT TO TAKEN WITH PROPER LANDING; TEST DIFFERENT TAKES AND OBSERVE THE EFFECTS ON THE OPERATION OF THE EQUIPMENT. (2) IMPLEMENT AN ENERGY QUALITY PROGRAM IN PARTNERSHIP WITH THE ELECTRICITY COMPANIES, HOSPITAL OFFICIALS AND FINAL USERS TO MINIMIZE THE INTERFERENCE OF DRIVING CABLES AND ENERGY FREQUENCY. ECRI RECOMMENDS THAT YOU ALWAYS CONSIDER EMI AS A POTENTIAL SOURCE OF THE MALFUNCTIONING OF EQUIPMENT, ESPECIALLY WHEN THE READING OF THE EQUIPMENT SEEMS TO BE AFFECTED BY NOISE, SORRY OF THE EQUIPMENT BE DULY CONNECTED AND POSTED TO THE PATIENT. IF ANY EMI PROBLEMS ARE SUSPECTED, CHECK THE DOCUMENTATION OF ANY ELECTRONIC HOSPITAL EQUIPMENT THAT IS BEING USED IN THE AREA. WHEN YOU ARE VERIFYING THE DOCUMENTATION, ECRI RECOMMENDS YOU TO VERIFY: (1) IF THE EQUIPMENT IS CLASS A OR B, BECAUSE THE CLASS EQUIPMENT IS EMITTED TO GREATER ELECTROMAGNETIC ENERGY, AND (2) EMI'S SPECIFIC RECOMMENDATIONS FROM THE MANUFACTURER. ECRI RECOMMENDS THAT USERS AND CLINICAL ENGINEER EMPLOYEES SHOULD ALWAYS BE ALTHOUGH YOU HAVE EMI PROBLEMS. IN ADDITION, ECRI RECOMMENDS THAT EMPLOYEES SHALL BE INFORMED OF THE EFFECTS EMI MAY HAVE IN THE OPERATION OF EQUIPMENT AND RECOMMENDATIONS BY ECRI FOR THE REDUCTION OR DISPOSAL OF INTERFERENCE. FOR FURTHER INFORMATION REGARDING ECRI'S EMI RISK REPORT, CONTACT CARLOS FORNAZIER, AT THE ELECTRONIC MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR BY PHONE 0XX-61-4481331.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Batches 710030.095 (per 08.03.2001) and 710030.097 (per 06.03.2001) of the IMMUNOCARD H. PYLORI reagent / reference 710030 of MERIDIAN DIAGNOSTICS EUROPE FRANCE are withdrawn from the market due to the possibility of obtaining false results. negative.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
The batches 9342298 (per 01.07.01) and 9327298 (per 01.10.01) of the reagent denominated BD BACTEC SIRE reference 442102, of the company BECTON DICKINSON BIOSCIENCES are withdrawn from the market following a mislabeling. A new test is recommended for samples that have been found either resistant to streptomycin and isoniazid, or sensitive to streptomycin and isoniazid.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 54 TROPONINE Ic reagent (references A110631 / A110632 / A116993 / A116994, used on systems ACS: 180 and ADVIA Centaur) of the company BAYER DIAGNOSTICS was withdrawn from the market, at the initiative of the manufacturer, 04.09 .2000, following the aggregation of the magnetic particles in the solid phase on some cartridges.
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
An ecri member hospital reports that when using the model 0606-0300-50 laserscope pulsar / carbon dioxide (co2) lasers for throat surgery, the otolaryngologist complained that the helio / neon laser beam (hene) , which indicates the area where the laser will reach the tissue, was not clear enough to be used.
Acción
ECRI makes the following recommendations: (1) Examine the target beam conditions of any Pulsar / Paragon CO2 laser in your hospital during inspection and preventive maintenance to detect any wear of the attenuator over time. Make sure that the aiming beam is immediately visible, especially when used with external light sources. (2) If the beam does not appear to be clear enough, make sure it is set to maximum intensity. If this does not solve, exclude other problems, such as those involving the micro manipulator or wear of the HeNe tube or the power source. (3) If the attenuator is the problem, consider removing the HeNe attenuator assembly (or ask the Laserscope manufacturer to do so). By doing so, you will be avoiding the effort and expense of having to incorporate a Laserscope crosshair upgrade kit, however this will also eliminate the ability to adjust the beam brightness (4) If this does not work , install the Laserscope NeHe upgrade kit. Contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States to discuss this option. It may be covered by the original service agreement (warranty) or warranty. Otherwise, Laserscope has stated that the total cost of the service is $ 3,900 (including labor and travel). For more information, contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States at fax 1 (408) 428-0512, or visit the Laserscope Web site at http: / /www.laserscope.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
The united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
Acción
MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION.
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 united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
Acción
MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION
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 united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
Acción
MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION.
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 united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
Acción
MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION.
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 failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM.
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 failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM
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 failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM.