Field Corrective Actions - Archive 2011
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 854 (35 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2011.12.30 | 5740/11 |
Safety Information for the device CyberKnife Systems with the Lung Optimized Treatment Option, Accuray Inc. Accuray Incorporated informs about a potential risk regarding the device CyberKnife Systems with the Lung Optimized Treatment Option.
|
Radiotherapy/ Radiation protection |
| 2011.12.29 | 5982/11 |
Lot Recall for the Profemur® AM Stem Ti Plasma, Wright Medical Technology Inc. Wright Medical Technology Inc.: Recall of two lots of the Profemur® AM Stem Ti Plasma due to a mix up in the packaging.
|
Non-active implants |
| 2011.12.29 | 5786/11 |
Safety Notice/Recall for Mini Crosser M1, Mini Crosser A/S The company Mini Crosser A/S has issued a field safety notice to its customers about the recall of the Mini Crosser M1. The recall applies to all Mini Crosser M1 manufactured before December 14th. There is the risk that the wrong setting of the controller the scooter might start driving all by itself.
|
Orthopedy/ Rehabilitation |
| 2011.12.29 | 2601/11 |
Safety Notice for Monosyn Violet 3/0 (2) 70 CM HR26 (M), Braun Surgical Braun Surgical informs about a mislabeling issue regarding the device Monosyn Violet 3/0 (2) 70 CM HR26 (M); Batch: 1-8456.
|
Dressings/ Drapery |
| 2011.12.28 | 5767/11 |
Recall of ACROBAT, ACROBAT V, ACROBAT SUV, XPOS 3 and XPOs 4, Maquet Maquet recalls batches of the Mechanical Stabilizers ACROBAT, ACROBAT V, ACROBAT SUV and of the XPOS 3, XPOs 4 Positioners due to potentially un-sterility caused by problems of packaging.
|
Medical instruments |
| 2011.12.23 | 5933/11 |
Corrective action of surgical lighting systems iLED and TruLight, Trumpf Medizin Systeme GmbH & Co. KG Trumpf Medizin Systeme GmbH & Co. KG has issued a Field Safety Notice concerning a corrective action of the surgical lighting systems iLED and TruLight. Due to a tight handle socket the Sterilisable Handle ALC, material number 1583966, may not lock in the catch provided and as consequence of this it may fall off into the surgical field. All handles of this type will be replaced with new handles made with an increased tolerance.
|
Surgical equipment/ Anaesthesia |
| 2011.12.23 | 5764/11 |
Field Safety Notice regarding power cords supplied with certain models of AIRVO PT100 and PT101 humidifiers, Fisher & Paykel Fisher & Paykel has issued a Field Safety Notice regarding the power cords supplied with certain models of AIRVO PT100 and PT101 humidifiers.
|
Surgical equipment/ Anaesthesia |
| 2011.12.22 | 3576/11 |
Problem with Optical Guidance Platform (OGP), Varian medical systems Varian medical systems has issued a field safety notice concerning a problem that has been identified with the Optical Guidance Platform (OGP), v2.6 and 2.6.1 of a possible infrared light reflection resulting in an inability to calibrate the OGP or track the optical guidance tool during use. As a result, the OGP may be unable to track the positioning tool or in one reported case, display an improper correction vector.
|
Radiotherapy/ Radiation protection |
| 2011.12.22 | 5363/11 |
Field Safety Notice concerning a corrective action of the electrocardiogram (ECG) Screening software, Spacelabs Healthcare Spacelabs Healthcare has issued a Field Safety Notice concerning a corrective action of the electrocardiogram (ECG) Screening software version 3.31. If Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System the file can get corrupted or a wrong ECG can occur. This can only happen if both recordings are greater than 32 hours long.
|
Medical electronics / Electromedical devices |
| 2011.12.22 | 5363/11 |
Recall of several lots and adjustments sets of the contact lens AVAIRA Sphere, CooperVision Manufacturing Inc. CooperVision Manufacturing Inc. is conducting a recall of several lots and adjustments sets of the contact lens AVAIRA Sphere. The recall was conducted due to residues (silicone oil) which can cause impairment of vision and in rare cases severe pain and eye injury requiring treatment. The additional information regarding the adjustment sets is only available in German.
|
Ophthalmological technology |
| 2011.12.22 | 3909/10 |
Absent wedge filter following plan load to Varian Treatment verify and record system, Varian medical systems Varian medical systems has issued a field safety notice concerning an absent wedge filter following plan load to the Varian Treatment verify and record system versions 6.6.5034, 6.6.5042, 6.6.5046, 6.6.5048, 6.6.5051 und 6.6.5052. This errant behavior was identified with Varian Treatment version 6.6.5052 connected to a Siemens Linac. It may also occur with Elekta Linacs and GE Linacs with the above versions of Varian Treatment.
|
Radiotherapy/ Radiation protection |
| 2011.12.22 | 5769/11 |
Field safety corrective action on electrosurgical unit ESG-400, Olympus Winter & Ibe GmbH The company Olympus Winter & Ibe GmbH is conducting a field safety corrective action on the electrosurgical unit ESG-400 (serial number lower than 28260W13-XXX). Affected products have to be returned for replacement of two capacitors C52 and C53. These capacitors may not be genuine products but counterfeit components which compromise function and safety of the unit. |
Medical electronics / Electromedical devices |
| 2011.12.22 | 5844/11 |
Safety issues on AW Server product, GE Healthcare GE Healthcare has issued a field safety notice concerning two seperate, unrelated safety issues on the AW Server product. The AW Server (AWS) may display incorrect patient name on images (Volume Viewer) or Tabs (Results Viewer).
|
Radiological technology |
| 2011.12.22 | 5552/11 |
Lot recall of Lenscare SH-System Monatslinsen (monthly lens), 4CARE AG The 4CARE AG is conducting a recall of several lots of the Lenscare SH-System Monatslinsen (monthly lens). The recall was conducted due to residues (silicone oil) which can cause impairment of vision and eye pain.
|
Ophthalmological technology |
| 2011.12.22 | 5678/11 |
Batch recall of Optiplug® Cement Restrictors, Integra LifeSciences Integra LifeSciences: Recall of one batch of Optiplug® Cement Restrictors. The internal patient chart labels have been labelled with an incorrect expiry date.
|
Non-active implants |
| 2011.12.22 | 5588/11 |
Lot recall for Vancomycin Calibrators (Lot-No. 59391741), ThermoFisher Recall of ThermoFisher for Vancomycin Calibrators (Lot-No. 59391741) due to an incorrect calibration. Customers were advised to discard the affected batch.
|
In-vitro diagnostics |
| 2011.12.20 | 4697/11 |
Recall for Terumo Sarns Adult Rigid Intracardiac Suckers, Terumo Europe NV Terumo Europe NV recalls Terumo Sarns Adult Rigid Intracardiac Suckers from the Market. The suckers may have metal fragments inside the stainless steel tube of the sucker.
|
Surgical equipment/ Anaesthesia |
| 2011.12.16 | 5782/11 |
Recall of the device NL8600401 – Non-sterile stainless steel stepdown connector, Integra NeuroSciences Integra NeuroSciences is conducting a recall of the connector “NL8600401 – Non-sterile stainless steel stepdown connector”. On the IFU of the product which is visible through the packaging is a reference to the related sterile shunt kit. This may lead to the wrong assumption that the connector is sterile.
|
Non-active implants |
| 2011.12.16 | 5698/11 |
Safety Notice for the FrameArray Module (of the Optical Guidance Platform), Varian medical systems Varian medical systems has issued a field safety notice concerning an anomaly that has been identified with the Head ring posts used by both the Optical Guidance Platform (OGP) FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechnical stress resulting in possible failure during usage.
|
Radiotherapy/ Radiation protection |
| 2011.12.16 | 5501/11 |
Recall for AIA-PACK ß HCG Calibrator Set, TOSOH Bioscience Recall of TOSOH Bioscience for AIA-PACK ß HCG Calibrator Set (Lot-No. B733581) due to incorrect product substances. Customers were advised to discard the affected batch.
|
In-vitro diagnostics |
| 2011.12.16 | 5590/11 |
Safety Notice for 4D Structure Merge Tool Option in Eclipse Release 8.5-10 with 4D Planning, Varian medical systems Varian medical systems has issued a field safety notice concerning a problem use of 4D Structure Merge Tool Option in Eclipse Release 8.5-10 (client build 8.2.2x through 10.0.34) with 4D Planning.
|
Radiotherapy/ Radiation protection |
| 2011.12.15 | 5644/11 |
Lot Recall of 1 DAY ACUVUE MOIST contact lenses, Johnson & Johnson Vision Care Johnson & Johnson Vision Care is conducting a recall of one lot (B00BVTN) of the contact lens 1 DAY ACUVUE MOIST. The values on the outer carton label are not the same as on the blister.
|
Ophthalmological technology |
| 2011.12.15 | 5605/11 |
Safety Notice concerning Revolution XR/d X-ray Systems, GE Healthcare GE Healthcare has issued a Field Safety Notice concerning Revolution XR/d X-ray Systems. The Table Hand grip may dislodge during use and therefore should be removed from use until the product is corrected.
|
Radiological technology |
| 2011.12.15 | 5563/11 |
Safety Notice for Riata and Riata ST Silicone Endocardial Defibrillation leads, St. Jude Medical St. Jude Medical has issued a Field Safety Notice concerning endocardial silicone leads Riata and Riata ST of several model numbers.
|
Active implants |
| 2011.12.15 | 3409/11 |
Additional Information: Lot Recall of different dialysis tubing systems, Gambro The manufacturer Gambro recalls several lots of different dialysis tubing systems. The FSCA follows in addition to the manufacturer’s FSN of 2011-09-20.
|
Injection/ Infusion/ Transfusion/Dialysis |
