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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Potential for activation of an abnormal alarm pause.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Potential for barb non-engagement.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Due to software issue, radiology reports may not be fully displayed when viewing.
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Limited system movements after startup .
Their is the potential for weak staining which may result in false negative CD20 identification.