Medical Devices Recalls

Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie

The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm

Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.

The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.

Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm

Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.

This recall has been initiated due to the product labeled with the incorrect expiration date.

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.

DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.