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For certain nuclear medicine systems, GE Healthcare has become aware that a mitigation may not be correctly implemented. If this is the case, the detector can fall leading to life-threatening bodily injury. Recall start date: December 18, 2022

The replacement silicone sound abatement foam installed into the Trilogy 100 and Trilogy 200 devices identified in this letter may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air…

Philips has identified an issue where a specific component failure in the gradient coil of where the affected 3T MR Systems identified above may act as a heat source, with a potential to produce smoke and/or fire.  If the components failure…

Affected lot may result in a false negative for skin test (peanut allergy).

Infolding is a known phenomenon and occurs when the valve frame folds inward along a vertical line away from the valve inflow and appears as a seam in the frame or as overlapping frame cells on radiographic imaging. Infolding is different and distinct…

Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier…

Baxter Corporation is issuing an urgent medical device correction related to two different software issues that occur during use. The first issue observed is due to incorrect reported delivered volume while an infusion is running. The second issue…

Affected lot contains active ingredient (Cholecalciferol) levels outside of the labelled claim.

Teleflex has initiated a voluntary field safety corrective action due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices can be powered either by connecting to an ac power source…

Affected lot may result in a false negative for skin test (peanut allergy)

Intravenous bag may be leaking in affected lots.

Affected lot is labelled with the incorrect strength and ingredient  

Through ongoing internal testing, Baxter Corporation has observed isolated incident of over infusion on the Novum IQ LVP infusion pump during test runs at 0.1 ml/hr after 40 hours of continuous infusion within the 96-hour set change interval. Recall…

Medtronic is issuing a voluntary medical device correction related to specific serial numbers of the turbine component of Puritan Bennett 500 series ventilators. This voluntary medical device correction is being issued following confirmation of six…

Affected lot may contain particulate matter