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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…

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…

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…

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…

Abbott has identified that a subset of Assurity and/or Endurity pacemaker(s) are impacted by a manufacturing issue.  As background, the issue in this recall is connected to a manufacturing laser roughening process, unique to a single assembly site…

A bug has been detected in the planning software. When loading images, there may be a left/right inversion. Display of image series is flipped after importing a sagittal oriented image series stored using the enhanced Dicom format. Recall start date:…

Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints…

Smiths Medical implemented a design change in 2016 to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. Smiths Medical has become aware that…

Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

Medtronic is informing customers of product performance issues related to the Heartware Ventricular Assist Device (HVAD) system batteries. Medtronic is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified…

Our contract manufacturer sent us a FSCA identifying deviations in their sterilisation process and therefore we can not guarantee the sterility of the products. Recall start date: May 18, 2022