Field Corrective Actions - Archive 2007
Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, and to advise on what action should be taken to protect the health or the safety of patients, users or other persons. For example, advisory notices may contain the information from the manufacturer that he voluntarily recalls a medical device.
Please note that advisory notices are issued by the manufacturer, the authorized representative or the importer of medical devices. The respective company takes the responsibility for all information given in the advisory notice.
Search results 1 to 25 from a total of 537 (22 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2007.12.21 | 0587/07 |
Information for Evolution beds, Hill Rom Hill Rom GmbH has reissued a customer information on the regulations concerning accepted dimensions of side rails and about the necessity the refit Evolution beds, manufactured before the year 2000.
|
General equipment for medical treatment |
| 2007.12.21 | 4519/07 |
Recall of VITEK 2 GP identification cards, BioMérieux BioMérieux recalls VITEK 2 GP identification card lot 242083040 due to mislabelling.
|
In-vitro diagnostics |
| 2007.12.21 | 4322/07 |
Advisory Notice for O-ARM® Intraoperative Imaging Systems, Medtronic Medtronic has issued an Advisory Notice concerning the O-ARM® Intraoperative Imaging Systems in conjuction with the StealthStation®.
|
Radiological technology |
| 2007.12.21 | 4351/07 |
Information for PACS System EasyVision RAD Release 4.2 V2, Philips Philips Medical Systems has issued an information concerning a problem with the PACS System EasyVision RAD Release 4.2 V2. If any zoomed image is exported to a PACS then an electronic measurement on the PACS can give a wrong result because during the export process this image is sent with the new pixel matrix but the pixel size information in the image has not been changed. Philips will perform a software update version Easy Vision RAD R4.2 V2 LEVEL 7 SP 4 on all systems.
|
Radiological technology |
| 2007.12.20 | 4263/07 |
Corrective action for COBAS INTEGRA 400/400 plus systems, Roche Corrective action of Roche Diagnostics because of carry-over from LDL-Cholesterol assay to Lipase assay on COBAS INTEGRA 400/400 plus and from LDL-Cholesterol assay to the Lipase assay on cobas c 111. The customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2007.12.20 | 3881/07 |
Information for the Carendo Multi purpose Hygien Chair, Arjo The company Arjo GmbH has issued an information to its customers about the risk of getting jammed with the use of the Carendo Multi Purpose Hygiene Chair. There is a possibility, depending on the position of the patient and the constitution of the genitals of certain male patients that the genitals may be pinched between seat and framework during lowering movements of the seat. The manufacturer inserts a warning in the revised instruction for use. Advisory Notice is only available in German language.
|
Orthopedy/ Rehabilitation |
| 2007.12.19 | 3879/07 |
Information for the patient hoists Foldy, Torneo and Duo, Aktuelle Krankenpflege Systeme Aktuelle Krankenpflege Systeme GmbH has issued a customer information concerning the exchange of the cover of battery housing in patient hoist model Foldy, Torneo and Duo. Advisory Notice is only available in German language.
|
In-vitro diagnostics |
| 2007.12.19 | 4465/07 |
Corrective action for Dade Cardiac TL Assayed Cardiac Marker Control, ThermoFisher Corrective action of ThermoFisher Scientific for Dade Cardiac TL Assayed Cardiac Marker Control (B5960-1, B5960-2, B5960-S) with lot numbers CTL10041/CTL10041D, CTL10042/CTL10042D, CTL1004SD because of reduced open vial stability claim for NT-proBNP. The Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2007.12.19 | 4339/07 |
Recall of Complement Reagents (OWZD11), Dade Behring Recall of Dade Behring for Complement Reagents (OWZD11), lot number 542849, on the BCS® and BCT® systems because of an unexpected high variation. The Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2007.12.19 | 4102/07 |
Recall of Universal and Ultraclean Electrodes, ConMed The company ConMed Corp. issued an information concerning the device recall of Universal and Ultraclean Electrodes due to a possible inadequate package seal.
|
Medical electronics / Electromedical devices |
| 2007.12.17 | 4330/07 |
Recall of laryngeal masks, Besmed Besmed Health Business Corp. recalls one lot of the laryngeal masks from the market. The affected devices differ in size and form and cannot be placed safely into the airway. Advisory Notice is only available in German language.
|
Surgical equipment/ Anaesthesia |
| 2007.12.17 | 4397/07 |
Recall of Cemento Fixx, OptiMed Cemento Fixx: The company OptiMed has informed about a lot-recall of the bone cement. The action was initiated because of cases of an incorrect mixing and hardening behaviour.
|
Non-active implants |
| 2007.12.17 | 1595/05 |
Information for ARCHITECT Folate assay, Abbott Abbott informs that the ARCHITECT Folate assay has been restandardised and outlines the corresponding changes to the assay because of the downward shift in control and/or patient results (see also Device Correction Letter FA11MAR2005). Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2007.12.17 | 4300/07 |
Corrective action for CRP LX and CRP HS to cobas 6000<cc> und cobas 6000<cce>, Roche Corrective action of Roche Diagnostics for CRP LX and CRP HS to cobas 6000<cc> und cobas 6000<cce> because of potential false results. The customers were informed about the problem and how to avoid it. Advisory Notice is only available in German language.
|
In-vitro diagnostics |
| 2007.12.17 | 4415/07 |
Corrective action for Dimension clinical chemistry system Microalbumin Calibrator, Dade Behring Corrective action of Dade Behring for Dimension clinical chemistry system Microalbumin (MALB) Calibrator (DC114), Lot number 7HD049, because the use of the Lot will result in poor calibration and unacceptable recovery of Quality Control. Customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2007.12.17 | 4438/07 |
Recall / Corrective action for Triage Meter Pro, Software Version 5.02, BIOSITE Recall / Corrective action of BIOSITE for Triage Meter Pro (part numbers 55070 and 55071), Software Version 5.02 (up to and including 5.02.027) because of a software defect issue. The customers were informed about the problem and a software upgrade (version 5.02.028) with the Software Installation Instructions has been made available.
|
In-vitro diagnostics |
| 2007.12.17 | 4411/07 |
Information for Brilliance 6, 10, 16, 16P, 40, 64, BigBore und MX8000Dual v. EXP, Philips Philips issued an information concerning Brilliance 6, 10, 16, 16P, 40, 64, BigBore und MX8000Dual v. EXP CT scanners. Only those couches which have hade vertical brakes replaced by Philips Field Service may be affected. The couches may descend in uncommanded motion while the table is being moved vertically.
|
Radiological technology |
| 2007.12.17 | 4366/07 |
Recall of Singleday Infusor, Baxter Baxter recalls certain lots of the Singleday Infusor 2 ml/h from the market due to leakages at the distal tube end. Advisory Notice is only available in German language.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2007.12.17 | 3810/07 |
Recall of Smart Seal Pressurisers, DePuy Recall of the products Smart Seal Pressurisers: femoral and acetabular pressurisers (5pack) for use with orthopedic cement (lots and article numbers see annex) from DePuy. The products are withdrawn because some outer pouch seals are creased. The sterility of the products is not guaranteed.
|
Medical instruments |
| 2007.12.13 | 4350/07 |
Information for DigitalDiagnost, BuckyDiagnost, EasyDiagnost und Thoravision systems, Philips Philips informed all user of DigitalDiagnost, BuckyDiagnost, EasyDiagnost und Thoravision systems about an fixation problem of the collimator. Collimator may fall down due to loose srews. The manufacturer plans a modification to eliminate any risk.
|
Radiological technology |
| 2007.12.13 | 3315/07 |
Recall of the wheelchairs Invacare Action², Invacare/Aquatec The company Invacare/Aquatec GmbH has issued an information to its customers about the recall of the wheelchairs Invacare Action², manually propelled. The recall concerns wheelchairs produced in 2006. There is the risk that plastic staves of the seat covering could break and the patient can slip from the wheelchair and could get injuries. Advisory Notice is only available in German language.
|
Orthopedy/ Rehabilitation |
| 2007.12.13 | 3998/07 |
Recall of Blood Grouping Reagent Anti-Le BioClone 2.0, Ortho-Clinical Diagnostics Recall of Ortho-Clinical Diagnostics for Blood Grouping Reagent Anti-Le BioClone 2.0 (Product Code 6901859) of Lot LAB129AX (Exp. 10.03.2008), Lot LAB130AX (Exp. 29.06.2008), Lot LAB131AX (Exp. 07.12.2008) because of complaints of weakened reactivity or false negative reactions. The customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2007.12.13 | 0570/07 |
Recall of PEEP valves, Ambu The manufacturer Ambu extends the recall of the PEEP valves to further lots. Advisory Notice is only available in German language.
|
Surgical equipment/ Anaesthesia |
| 2007.12.13 | 2989/07 |
Information ClosureFAST™ catheter, VNUS Medical Technologies VNUS Medical Technologies Inc. Informs the users per customer letter about the correct handling of the ClosureFAST™ catheter. In case of wrong placement of the catheter tip coagulation may be initiated at unintended location.for
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2007.12.13 | 4061/07 |
Recall of Elefant® Suction-Irrigation Device, Coloplast The company Coloplast issued an information concerning the recall of the Elefant® Suction-Irrigation Device for laparoscopy. The manufacturer is not able to guarantee the sterility of these products according to ISO 11135 standard.
|
Optics / Precision mechanics |
