ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Merge RadSuite software. Radiological image processing system.
Merge Healthcare
Class I - Dangerous
When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Class I - Dangerous
Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Class I - Dangerous
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Omega Medical Imaging
Class I - Dangerous
Elevating Monitor Suspension separated from the lifting column bracket
Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.
Tip Breakage at the glue joint between the obturator body and tip
Class I - Dangerous
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Class I - Dangerous
Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Class I - Dangerous
Tip Breakage at the glue joint between the obturator body and tip
Class I - Dangerous
Shipping carton labeling error.
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Arrow International
Class I - Dangerous
Shipping carton labeling error.
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.