Reason: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specificatio...
Reason: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specificatio...
Z-0796-2018March 7, 2018Toano, VA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascu...
Reason: There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480...
Reason: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specificatio...
Z-0797-2018March 7, 2018Toano, VA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, in...
Reason: Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two...
Z-0717-2018March 7, 2018Andover, MA
Boston Scientific Corporation
Class IIOngoing
VISIONIST CRT-P Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0365-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ALTRUA 2 DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0363-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ACCOLADE SR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0354-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ESSENTIO MRI DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0370-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ACCOLADE EL DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0356-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ACCOLADE DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0355-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
PROPONENT VDD SL Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0376-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ESSENTIO SR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0367-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ACCOLADE MRI EL DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0359-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
VALITUDE CRT-P Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0360-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ACCOLADE MRI DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0358-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
PROPONENT DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0374-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ESSENTIO DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0368-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
PROPONENT EL DR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0375-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ACCOLADE MRI SR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0357-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
VALITUDE X4 CRT-P Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0361-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
PROPONENT MRI Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0377-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ALTRUA 2 SR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0362-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
VISIONIST X4 CRT-P Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...
Z-0366-2018January 24, 2018Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
ESSENTIO MRI SR Pacemaker
Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronizat...