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
These reagents may produce false, high creatinine results due, but not limited to, high serum levels of triglycerides. roche started the urgent removal day december 20, 2000.
Acción
PLEASE CHECK THAT YOU HAVE RECEIVED THE ROCHE DIAGNOSTIC CORRECTIVE LETTER OF DECEMBER 20, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL PRODUCTS THAT MAY BE AFFECTED AND ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT DAGNOSTIC ROCHE ON THE PHONE.
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 received reports indicating that while the cylinders with gases compressed identifying their contents, the staff of the hospital can inadequately trust in secondary indicators like the color of the cylinders or the pins of the connect.
Acción
MAKE SURE ALL YOUR RELATED STAFF ARE ADEQUATELY TRAINED AND DISTRIBUTE THIS ALERT FOR EVERYONE. PERIODIC UPDATE COURSES OR NEW EMPLOYEES ARE IMPORTANT TO PREVENT RISK. (1) WHEN CHOOSING A CYLINDER FOR USE SHOULD READ THE LABEL TO BE SURE THAT IS THE CORRECT GAZ. CAUTION TO SEE THE COLOR IS ADDITIONAL. CHECK THAT THE CYLINDER GAZ OUTPUT AND THE GAZ ENTRY INTO THE SITEMA TO BE ADJUSTED PERFECTLY. DO NOT ASSUME THAT THE COVER OR CONNECTION CAN CORRECTLY IDENTIFY THE GAZ CONTAINED IN THE CYLINDER. IF THE LABEL IS MISSING OR IS NOT LEVELABLE, DO NOT USE THE CYLINDER. IF THE CONNECTORS ARE COMPATIBLE, DO NOT MODIFY THE CONNECTORS OR USE THE CYLINDER, SEE WHAT IS WRONG. (2) IN THE NEXT EQUIPMENT INSPECTION, ENSURE THAT ALL THOSE WHO USE CYLINDERS HAVE THEIR PINS AND CONNECTORS FOR THE SPECIFIC GAZ CYLINDERS REQUIRED. (3) DO NOT REMOVE OR MODIFY GAZ CONNECTORS WITHOUT CONSULTING THE EQUIPMENT MANUFACTURER. (4) DO NOT BUY MEDICAL GAS CYLINDERS WITH CRADLE DIAGRAMS OR NON-STANDARD CONNECTORS.
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
07/18/2001 - BRAZIL - THE COMPANY COMERCIAL MEDICA LTDA, INFORMES THAT THE IMPORTATION OF THE SERIES AFFECTED TO BRAZIL WAS NOT OCCURRED. IT FURTHER INFORMES THAT, AT INTERNATIONAL LEVEL THE PROBLEM WAS RESOLVED AND COMMUNICATED TO THE FDA.
Causa
May cause insufficient discharge of energy to patients with transtorcaic impedance <30 phms.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON 13 / DECEMBER / 2000. IDENTIFY AND INSULATE THE PRODUCT. ZOLL RECOMMENDS: (1) ALERT OPERATORS OF POSSIBLE DYSFUNCTION. (2) IF ANOTHER PRODUCT IS NOT AVAILABLE, RENT ONE AND REMOVE THE PRODUCT OF THE USE, UNTIL IT IS TESTED. IF NEEDED SERVICES OR FOR FURTHER INFORMATION, TELEPHONY TO ZOLL, 00XX1 (781) 229-0020.
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
Under certain circumstances, you may fail to turn on electricity or it is possible to turn off due to a dysfunctional capacitor in the unit circuit.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON 5 FEBRUARY 2001. IDENTIFY AND INSULATE THE PRODUCT. AGILENT RECOMMENDS: (1) ALERT OPERATORS OF POSSIBLE DYSFUNCTION. (2) AGILENT WILL PHONE MARCH-APRIL TO COME REPAIR. IF ANOTHER PRODUCT IS NOT AVAILABLE, FOLLOW THE FOLLOWING INSTRUCTIONS TO REDUCE THE RISK OF FAULTS. THE FOLLOWING TEST IS ONLY REQUIRED ONCE AND IS MORE EFFECTIVE AT THE MAXIMUM TEMPERATURE THAT THE EQUIPMENT IS SUPPLIED TO OPERATE, UNTIL IT IS REPAIRED. (1) WITH THE UNIT TURNED OFF, INSERT YOUR NEW BATTERY COMPLETELY CHARGED, SWITCH ON THE AC OR DC UNIT IN THE ELECTRICITY AND WAIT UNTIL YOU SEE THE GREEN SIGN ON THE ELECTRICITY MODULE. (2) TURN ON THE UNIT AND WAIT UNTIL MONITOR LIGHTING FOR AT LEAST 10 SECONDS AND SWITCH OFF. (3) REMOVE THE BATTERY AND DISCONNECT ELECTRICITY. (4) TURN ON THE UNIT (NOTE THAT IT DOES NOT LIGHT) AND TURN OFF. LEAVE IT OFF FOR 1 MINUTE. (5) RE-INSERT THE SAME BATTERY. (6) TURN ON THE UNIT, AND WAIT UNTIL MONITOR LIGHTING FOR AT LEAST 10 SECONDS AND SWITCH OFF. (7) REMOVE THE BATTERY. (8) REPEAT STAGES 4 TO 7 FIVE TIMES. (9) RUN THE SHIT / SYSTEM TESTER (SEE YOUR INSTRUCTION MANUAL) AND MAKE SURE THAT THE UNIT PERFORMED IN VERIFICATION. AGILENT ALSO SUGGESTS THAT WHEN POSSIBLE, LEAVE THE DC OR AC UNIT ON THE ELECTRICITY SO THAT IT IS NECESSARY TO INSERT BATTERY DURING USE. IF YOU NEED BATTERY, ALWAYS HAVE A COMPLETELY LOADED RESERVE. AFTER ANY BATTERY INSERTION, TEST THE UNIT: CALL AND SEE IF THE MONITOR IS LIGHTED, THEN IF THE PRODUCT IS NOT IN USE IN A PATIENT AND SWITCH OFF. FOR FURTHER INFORMATION, TELEPHONE TO LOCAL AGILENT.
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
Stability tests indicated that useful life is less than expected. control and patient values may be below real.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON DECEMBER 19, 2000. RELEVANT LABORATORIES MUST CHECK THAT THEY RECEIVED THE NOTIFICATION OF THE MEDICAL ANALYSIS SYSTEMS. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. THE LABORATORY MANAGER MUST COMPLETE THE FORM AND REQUIRE REPLACEMENT OF THE AFFECTED KITS, AT FAX 00XX1 (805) 987-6498. FOR FURTHER INFORMATION, TELEPHONE TO PHARMACY, 00XX1 (805) 987-7891.
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
Possible insertion difficulty of the recommended 0.038 inch guide at the terminal point of the introduction guide.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON 22 / SEPTEMBER / 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED MEDTRONIC NOTIFICATION. YOU SHOULD IDENTIFY, REMOVE FROM THE USE, YOUR INVENTORY AND RETURN THE AFFECTED PRODUCTS AS INDICATED IN THE MANUFACTURER'S LETTER. FOR FURTHER INFORMATION, TELEPHONY TO CHRIS CAMPBELL-LOTH, MEDTRONIC, 00XX1 (763) 514-8547.
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
Laser use manuals violate health law as no longer recommended agenda for maintenance procedures including calibration periodicity.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON JANUARY 18, 2001. RELEVANT HOSPITALS, CLINICS AND SURGEONS SHOULD VERIFY RECEIPT OF NOTIFICATION AND ECLIPSE URGENT RESPONSE FORM. IMMEDIATELY DISCONTINUE USE OF THIS MANUAL, DISCONTINUE AND REPLACE WITH THE NEW VERSION. COMPLETE THE ECLIPSE URGENT RESPONSE FORM AND RETURN BY FAX 00XX 1 (408) 548-2169. FOR FURTHER INFORMATION, TELEPHONY TO ECLIPSE NO 00XX 1 (408) 465-1121.
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
After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. not ho.
Acción
ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE LEAVING.
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 interface may not detect the existence of the nerve, resulting in irreversible damage during operation.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON JULY 31, 2000. HOSPITALS, CLINICS AND RELATED SURGEONS MUST CHECK THAT THEY RECEIVED MEDTRONICS NOTIFICATION. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. THE AFFECTED INTERFACE UNITS CAN BE DIFFERENTIATED FROM THE STANDARD MODELS BY THE MISSING DECALCOMANY SEAL AROUND THE CABLE NEXT TO THE CONNECTION TO THE MONITOR. FOR FURTHER INFORMATION, CALL MEDTRONIC XOMED, 00XX1 (904) 296-9600.
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 interface may not detect the existence of the nerve, resulting in irreversible damage during operation.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON JULY 31, 2000. HOSPITALS, CLINICS AND RELATED SURGEONS MUST CHECK THAT THEY RECEIVED MEDTRONICS NOTIFICATION. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. THE AFFECTED INTERFACE UNITS CAN BE DIFFERENTIATED FROM THE STANDARD MODELS BY THE MISSING DECALCOMANY SEAL AROUND THE CABLE NEXT TO THE CONNECTION TO THE MONITOR. FOR FURTHER INFORMATION, CALL MEDTRONIC XOMED, 00XX1 (904) 296-9600.
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
Aluminum filiformes fragments of potes beads were detected on powder and gazes.
Acción
THE MANUFACTURER STARTED WITHDRAWAL ON NOVEMBER 17, 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED THE NOTIFICATION OF THE PHARMACY. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. FOR FURTHER INFORMATION, TELEPHONE TO PHARMACY, 00XX1 (908) 901-8000.
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
BRAZIL - 08/14/2001. THE KNEE SUPPORT OF NEOPRENE IS A NATIONAL MANUFACTURING PRODUCT, MADE BY THE COMPANY SALVAPÉ PRODUTOS ORTOPÉDICOS LTDA. IT ALSO INFORMES THAT IT IS NOT AN IMPORTED PRODUCT OF THE "ROYAL" COMPANY.
Causa
Not declared correct composition of the products: there is natural rubber that had not been declared. the manufacturer began a correction by letter of december 12, 2000.
Acción
VERIFY THAT YOU HAVE RECEIVED THE DEROYAL LETTER OF DECEMBER 12, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. DEROYAL AFFIRMS THAT THE PRODUCTS MAY BE RETURNED FOR LABEL CORRECTION, OR USERS MAY REQUIRE THE NEW LABELS AND CORRESPOND IT ON THE PRODUCTS. FOR FURTHER INFORMATION CONTACT DEROYAL ON PHONE 0021-1-423-938-7828.
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
Unit software causes data storage errors in specific circumstances. if the user tests when the watch records 12 hrs, midday or midnight, the apparatus mark 1 day of the 7 day cycle and the test is icorretamentally warm.
Acción
VERIFY THAT YOU HAVE RECEIVED THE ROCHE DAGNOSTIC URGENT CORRECTION LETTER ON MARCH 30, 2001. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT DAGNOSTIC ROCHE ON THE PHONE.
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
Reagent bottle is badly positioned. this bad position causes very lackable light signals, resulting in calibration failure, error code or results of 0,0 ng / ml. the distributor began a letter correction and temporary review of protocols.
Acción
VERIFY THAT YOU HAVE RECEIVED THE LETTER AND THE TEMPORARY REVISED QUALITY CONTROL PROTOCOLS OF JANUARY 26, 2001 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. IMPLEMENT THE TEMPORARY PROTOCOL ON ALL AFFECTED PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.
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
These pump assemblies have insufficiently lacrated external packaging, committing its sterility. the distributor began a correction by letter of december 18, 2000.
Acción
VERIFY THAT YOU HAVE RECEIVED THE POSSIBLE LETTER OF DECEMBER 18, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT JAMES GUSTAFSON, AT POSSIS, BY PHONE 0021-1-763-780-4555.
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
Reagent bottle is badly positioned. this bad position causes very lackable light signals, resulting in calibration failure, error code or results of 0,0 ng / ml. the distributor began a letter correction and temporary review of protocols.
Acción
VERIFY THAT YOU HAVE RECEIVED THE LETTER AND THE TEMPORARY REVISED QUALITY CONTROL PROTOCOLS OF JANUARY 26, 2001 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. IMPLEMENT THE TEMPORARY PROTOCOL ON ALL AFFECTED PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.
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
Occurrence of a high number of incidents associated with whippers for different lots of the product during the insulin administration with pre-loaded syringes. the insufficient or inefficient performance of the needles compors serious risks to the health of the diabetic population, for insufficient metabolic control of the disease.
Acción
COLLECTION OF ALL LOTS OF OMNICAN H MINHI NEEDLES 0.3 X 8 MM AND OMNICAN 0.30 X 8 MM WITHIN 10 DAYS
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 results of non-conjugated bilirubin can result less than 0.0 mg / dl or the results of the conjugated bilirubin can not sign the potential interference codes when a spectral interference is existed in a sample of the patient. the problem.
Acción
VERIFY THAT YOU HAVE RECEIVED THE LETTER OF OCTOBER 6, 2000 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. . IDENTIFY THESE SYSTEMS THAT MAY BE WITH AFFECTED VERSIONS IN YOUR INVENTORY. ORTHO-CLINICAL DIAGNOSTICS AFFIRMS THAT VERSION 7.0 OR MORE FOR THE SITEMAS VITROS 250 OR 250 AT CORRECTED THE PROBLEM. SOFTWARE TO CORRECT THE PROBLEM WITH 950 AND 950 VOTES AT STILL NOT AVAILABLE. IF REPORTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN ARE REQUIRED, ORTHO-CLINICAL DIAGNOSTICS RECOMMENDS THE FOLLOWING: (1) REVIEW ALL REPORTS OF RESULTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN; (2) IF THE RESULTS OF NON-CONJUGATED BILIRUBIN ARE LOWER THAN THE ANALYZER INTERVAL, DO NOT REPORT THE CORRESPONDING CONJUGATED BILIRUBIN RESULT. (3) DO NOT USE THE PRINTED MONITOR RESULTS TO REPORT RESULTS OF UNLESS CONNECTED BILIRUBIN ANALYSIS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.
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
After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. not ho.
Acción
ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE LEAVING.
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
After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. not ho.
Acción
ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE LEAVING.
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 checked water into the insulin pump h-tronplus v100 was registered as "water test" for surface activities. this results in a case of infusion of the quantity equivalent to 8 days of treatment in just 45 minutes. the patient.
Acción
SEE THE CHARTER AND SUPPLEMENT OF THE MANUAL ON THE INTERNET: HTTP://WWW.DISETRONI-USA.COM ECRI AND THE MANUFACTURER RECOMMEND: (1) AVOID THAT BOTH PUMPS MINE. REMOVE THEM BEFORE BEGINING ACTIVITIES THAT SUBMIT THEM. (2) FOLLOW THE CHART INSTRUCTIONS, ONLY SWITCH THE POWER PACKS IN THE DRY ENVIRONMENT. WHILE REPLACING THE BATTERIES, MAKE SURE THE BLACK RING IS INSTALLED AND PROPERLY SEATED. (3) IF THE PUMP IS EVILUAL, BE INSPECTED TO CHECK THAT THEIR OPERATION IS CORRECT AND WATER INLET. BE ALERT TO SYMPTOMS OF SUPER-INFUSION: NERVOUS, HYPOTHERMIA, HEADACHE AND CONFUSION, SOME SEASONS OF CONVULSIONS AND EAT. FOR FURTHER INFORMATION CONTACT THE MANUFACTURER ON PHONE 0021-1-763-795-2000.
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 medical devices agency (uk) is advising that the adapter box of the unit's outlet can break and feel completely, expose the deprotected wires as a potential to cause electric shock a.
Acción
THE ENGLISH AGENCY RECOMMENDS: (1) IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT WERE PURCHASED IN 1999 AND 2000 THAT MAY BE IN YOUR INVENTORY. (2) DISCONTINUE THE USE OF THE PRODUCTS AFFECTED IMMEDIATELY, TURN OFF THE ELECTRICITY SWITCH AND REMOVE THE ADAPTER FROM THE OUTLET. (3) RETURN THE PRODUCTS AFFECTED TO THE REPRESENTATIVE TO REPAIR, REPLACE OR REIMBURSEMENT. (4) REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE UNITS. HEALTH PROFESSIONALS WHO KNOW PATIENTS USING THESE EQUIPMENT MUST ALERT THEM FROM THE POTENTIAL PROBLEM AND GUIDE THEM TO TAKE THESE CORRECTIVE MEASURES.
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
BRAZIL - COMPANY INSTRUCOM informs that the corrections have been implemented in the manufacturing line, therefore the product presents no risk to the patient or to the user.
Causa
White layers of waste in the humidity evaporator reservoir were reported with these incubators. in a report, the waste occurs the tube that connects the camera to the reservoir. this problem persisted even after the sterile water is replaced by ag.
Acción
IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN THEIR ALERT SETTING. THE MANUFACTURER AFFIRMS THAT THE RESERVOIR HAS BEEN MODIFIED BY PLACING A FLUORATED POLYMER COATING LAYER, SEALING, ON THE RESERVOIR ALUMINUM SURFACE TO PREVENT CORROSION AND AVOID WASTE FORMATION. THE MODIFIED RESERVOIR IS INCORPORATED IN ALL UNITS PRODUCED AS OF APRIL 21, 2000 AND IS AVAILABLE TO REPLACE IN UNITS WHICH NEED, HAVE RESIDUES, OR ARE NOT OPERATING. ECRI RECOMMENDS THE FOLLOWING: (1) NOTIFY YOUR PERSONNEL TO OBSERVE THAT WASTE AND WILL ALERT THESE POSSIBILITIES. REMEMBER ONLY WHAT DISTILLED WATER SHOULD BE USED. (2) IF DISTILLED WATER IS ONLY USED BUT WASTE WASTE TANKS, CONTACT THE MANUFACTURER TO REPLACE THE RESERVOIR [TELEPHONE: 0021-1-215-675-5200]. (3) EXAMINE THE CONDITION OF THE TUBES. PLEASE NOTE AND ALERT THAT THIS TUBE VERIFICATION MUST BE PART OF THE INSPECTION PROGRAM AND PREVENTIVE MAINTENANCE FOR EVERY 6 MONTHS.
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
Variation occurring oxygen concentrations may result in excessive or very insufficient exposures when units are operated in the incubator mode. variations arise from changes in fan speed when units are operated.
Acción
MAKE SURE YOU HAVE RECEIVED THE OHMEDA LETTER OF FEBRUARY 19, 2001, WITH A PRE-PAYMENT FORM FOR ANSWER AND WITH THE PAGES TO REPLACE IN THE OPERATION AND MAINTENANCE MANUAL. IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE MACHINES. TO CONTINUE TO USE THESE MACHINES SAFELY, OHMEDA RECOMMENDS: (1) USE ONLY WITH CONTROL-SERVER SYSTEM FOR FREE-FLOW OXYGEN ADMINISTRATION WITHIN THE CHILD'S COMPARTMENT. (2) REPLACE PAGES 3-7 AND 3-8 (SAME SHEETS, OPPOSITE SIDES) IN THE OPERATION AND MAINTENANCE MANUAL WITH THE PAGES THAT WERE SENT WITH THE ALERT LETTER, REMOVE ORIGINALS AND DESTROY THEM. (3) ON EACH UNIT, REMOVE THE ORIGINAL OXYGEN ALERT WARNING LABEL AND REPLACE THEM FOR THE SELF-COLLIER THAT HAS BEEN SENT TO YOU, ACCORDING TO THE GUIDELINES PROVIDED WITH THE LETTER. IF YOU ARE A SELLER OR DISTRIBUTOR TO OTHER PLACES, SEND A COPY OF THE NOTIFICATION LETTER AND ANSWER TO CONSUMERS. IF YOU NEED MORE COPIES OF THE LETTER CONTACT THE OHMEDA SECURITY ALERTS COORDINATOR BY PHONE 00XX1-410-888-5213. COMPLETE AND RETURN THE RESPONSE TO OHMEDA TO THE INDICATED ADDRESS (OHMEDA MEDICAL AN INSTRUMENTARIUM CO., 8880 GORMAN RD, LAUREL MD 20723 USA).
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 safety of the above monitors does not comply with international standards as declared in the marketing registry. neurosoft declares that the potential of electrical shock on the operator or patient is increased. the level of gravies.
Acción
THE MANUFACTURER STARTED WITHDRAWN IN. VERIFY THAT YOU HAVE RECEIVED THE NEUROSOFT LETTER OF OCTOBER 20, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN YOUR ESTABLISHMENT OF THE ALERT WITH THESE MONITORS AND DO NOT USE THEM. NEUROSOFT MUST REPLACE THEM BY MONITORS CONFORMING TO THE RULES. IF YOU ARE SUSPECTED THAT THERE WERE AGGRAVATIONS ASSOCIATED WITH THE USE OF YOUR A3000 SYSTEM, CONTACT THE NEUROSOFT TECHNICAL OFFICER BY PHONE 0021-1-703-904-7875. NEUROSOFT MUST AGENDE THE REPLACEMENT OF COMPONENTS NOT CONFORMING TO YOUR ESTABLISHMENT.