Field Corrective Actions
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.
RSS-Feed of Field Corrective Actions
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 342 (14 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2012.05.22 | 3439/12 |
Safety Notice for the Encore, Chorus and Sara Plus Standing and Raising Aids, Arjo Huntleigh The company Arjo Huntleigh has issued a field safety notice concerning the Encore, Chorus and Sara Plus Standing and raising aid. ArjoHuntleigh would like to remind users that the entire knee pad and support bracket assembly must be removed when required to do so for exercise.
|
Orthopedy/ Rehabilitation |
| 2012.05.22 | 2787/12 |
Safety Notice concerning the GH1 and GH3 Trolley guide, Guldmann A/S The company Guldmann A/S has issued a field safety notice concerning the GH1 and GH3 Trolley guide. Under special circumstance the hoist can move out of the rail. To prevent the GH1/GH3 Trolley from falling down, V. Guldmann A/S will remove the inner guide bush on all GH3 and GH1 trolley sets.
|
General equipment for medical treatment |
| 2012.05.21 | 3320/12 |
Recall for the AEROtube CSS1-1800-U1, CPAP-Universal-Tubing-System, HUM GmbH HUM GmbH recalls the batch 128000960 of the AEROtube CSS1-1800-U1, CPAP-Universal-Tubing-System because of a contamination with foreign particles.
|
Surgical equipment/ Anaesthesia |
| 2012.05.18 | 2537/12 |
Urgent Safety Notice for the INfusor, FOLfusor and Intermate products, Baxter The manufacturer Baxter has included a warning in the IFU of the elastomeric infusion pumps Intermate, FOLfusor and INfusor. Attention should be paid while infusing critical drugs.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2012.05.18 | 3102/12 |
Lot Recall for "BAYHA-Skalpellklingen Nr. 22 steril", C. Bruno Bayha GmbH C. Bruno Bayha GmbH recalls all lots manufactured in 2011 and 2012 of BAYHA-Skalpellklingen Nr. 22 steril because of potential insterility due to packaging problems. Advisory Notice is only available in German language.
|
Medical instruments |
| 2012.05.18 | 0802/12 |
Safety Information for the DALI LDL apheresis therapy, Fresenius The manufacturer Fresenius specifies the contra indications for the DALI LDL apheresis therapy.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2012.05.16 | 3347/12 |
Safety Information for the product Trabecular Metal Dental Implant, ZIMMER DENTAL Inc. To decrease the risk of fracturing the product Trabecular Metal Dental Implant a safety information including additional instructions is being sent by ZIMMER DENTAL Inc. /USA.
|
Dental products |
| 2012.05.16 | 3163/12 |
Recall of various sterile gauze products, Paul Hartmann AG The manufacturer Paul Hartmann AG informs about the recall of various sterile gauze products, because microholes were detected in the blister packagings.
|
Dressings/ Drapery |
| 2012.05.16 | 2868/12 |
Lot Recall for the implant Impla Mini balltop 2,5/9,5 mm, Schütz Dental GmbH The manufacturer Schütz Dental GmbH has initiated a lot recall of the product Impla Mini balltop 2,5/9,5 mm. Infection after insertion was noticed by a customer.
|
Dental products |
| 2012.05.16 | 5432/11 |
Recall of cemented 11 mm MML Adapter Stems, Orthodynamics Orthodynamics informs about a recall of cemented 11 mm MML Adapter Stems due to breakages and subsequent fatigue testing.
|
Non-active implants |
| 2012.05.15 | 2950/12 |
Corrective Action for oneHbA1c FS / oneHbA1c IS, DiaSys Corrective Action of DiaSys for oneHbA1c FS / oneHbA1c IS due to falsified results. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.15 | 3216/12 |
Corrective Action for BD Phoenix System Software and BD Phoenix Update Disks, Beckman Dickinson Corrective Action of Beckman Dickinson for BD Phoenix System Software and BD Phoenix Update Disks (PUD) due to an increase in false susceptible interpretations for vancomycin. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.15 | 2361/12 |
Safety Notice for the MITCH TRH System, DePuy The manufacturer DePuy notifies not to implant Finsbury MITCH TRH cups and MITCH TRH modulare heads with uncemented Stryker Accolade femoral stems.
|
Non-active implants |
| 2012.05.15 | 0021/12 |
Additional Field Safety Notice for ARCHITECT Active-B12, Abbott Additional field safety notice (BfArM 0021/12 date 20.1.2012) of Abbott for ARCHITECT Active-B12 due to a positive bias. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.14 | 2359/12 |
Corrective Action for Vitamin B12-Reagent Kit, Beckman Coulter Corrective Action of Beckman Coulter for Vitamin B12-Reagent Kit (Lot- No.: 170089) due to a manufacturing issue. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.14 | 3006/12 |
Lot Recall for the MultiLoc Proximal Humeral Nail, SYNTHES MultiLoc Proximal Humeral Nail: The company SYNTHES has informed about a lot recall of these bone nails. The action was initiated because of an error in such a way that the devices were manufactured without PE inlay and double threaded nut. Advisory Notice is only available in German language.
|
Non-active implants |
| 2012.05.14 | 2417/12 |
Corrective Action for AMPLILINK software v. 3.2, Roche Corrective Action of Roche for AMPLILINK software v. 3.2 due to a potential for wrong results. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.14 | 2685/12 |
Safety Notice for MLCi and MLCi2 Multileaf Collimators, Elekta Elekta has issued a field safety notice concerning a problem with the backup diaphragms drive mechanism. It is possible that the backup-diaphragms drive mechanism can become loose after many years.
|
Radiological technology |
| 2012.05.14 | 2119/12 |
Lot Recall for the Duisburg Hollow Screw for Subdural Puncture, TELEFLEX Duisburg Hollow Screw for Subdural Puncture: The company TELEFLEX has informed about a lot recall. The action was initiated because of a product error in such a way that the luer lock adapter of screw is oversized. Therefore, the screw does not fit in the screwdriver.
|
Non-active implants |
| 2012.05.14 | 2426/12 |
Corrective Action for Antimicrobial Susceptibility Testing Disc CN30 GENTAMICIN, Oxoid Corrective Action of Oxoid for Antimicrobial Susceptibility Testing Disc CN30 GENTAMICIN, CT0072B (Lot- No.: 1068119) due to a wrong packaging. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.11 | 2063/12 |
Lot Recall for the Valor® Targeting Guide and the Valor® TTC Fusion Instrument Set, Wright Medical Technology Wright Medical Technology recalls all lot numbers of the Valor® Targeting Guide and the Valor® TTC Fusion instrument set (only with model number 4150011000). The targeting device may become loose or can break.
|
Medical instruments |
| 2012.05.11 | 2677/12 |
Corrective Action for IMMULITE / IMMULITE 1000 folic Acid Kit, Siemens Corrective Action of Siemens for IMMULITE / IMMULITE 1000 folic Acid Kit (Lot- No.: 324,325,326) due to an invalid calibration. Customers were informed by the manufacturer.
|
In-vitro diagnostics |
| 2012.05.11 | 2957/12 |
Urgent Safety Notice for the 43-TRL-Inserter, Pioneer Surgical Pioneer Surgical requested the users to inspect the 43-TRL-Inserter prior to every use of proper functioning. While in use wear may cause that the trial spacer become detached from the inserter.
|
Medical instruments |
| 2012.05.11 | 2848/12 |
Recall of MEDRAD ® Continuum Pump and Tubing Set, Bayer HealthCare Bayer HealthCare is recalling all MEDRAD® Continuum MR Infusion System tubing sets (macrobore and microbore), catalogue numbers MIK 200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, 3015160 and 3015161. This tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2012.05.11 | 3210/12 |
Safety Notice for the RT-Plus Modular surgical technique, Smith & Nephew Smith & Nephew revised the RT-Plus Modular surgical technique instructions. Stepped Drill and Drill Guide should only used with manual driven handle. Powertool use may cause that the instruments get jammed and cause metal debris or bone defects.
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Medical instruments |
