Medical equipment, implants, and diagnostic devices
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach