Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

254 results found for pacemaker Page 6 of 11
Inpeco S.A.
Class II Terminated
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Ana...
Reason: The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual...
Z-0361-2019 November 7, 2018 Lugano, N/A
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
STREAMLAB - REFRIGERATED STORAGE MODULE 9000
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0216-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0217-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
APTIO RACK INPUT MODULE
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0210-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
APTIO INPUT/OUTPUT MODULE
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0209-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
APTIO RACK OUTPUT MODULE
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0214-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
APTIO 15000 REFRIGERATED STORAGE MODULE
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0212-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
APTIO 9000 REFRIGERATED STORAGE MODULE
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0213-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
APTIO CENTRIFUGE MODULE
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0211-2019 October 31, 2018 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
STREAMLAB CORE UNIT / LYNX WITH IOM
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Z-0215-2019 October 31, 2018 Tarrytown, NY
Boston Scientific Corporation
Class II Terminated
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Reason: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated b...
Z-3259-2018 October 3, 2018 Saint Paul, MN
Boston Scientific Corporation
Class II Terminated
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Reason: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated b...
Z-3258-2018 October 3, 2018 Saint Paul, MN
Boston Scientific Corporation
Class II Terminated
ESSENTIO Pacemaker
Reason: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated b...
Z-3255-2018 October 3, 2018 Saint Paul, MN
Boston Scientific Corporation
Class II Terminated
PROPONENT Pacemaker
Reason: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated b...
Z-3256-2018 October 3, 2018 Saint Paul, MN
Boston Scientific Corporation
Class II Terminated
ACCOLADE Pacemaker
Reason: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated b...
Z-3257-2018 October 3, 2018 Saint Paul, MN
Philips Healthcare
Class II Terminated
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications includin...
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had...
Z-2499-2018 August 1, 2018 Andover, MA
Philips Healthcare
Class II Terminated
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications i...
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had...
Z-2498-2018 August 1, 2018 Andover, MA
Philips Healthcare
Class II Terminated
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications inclu...
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had...
Z-2500-2018 August 1, 2018 Andover, MA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Single Chamber Temporary External Pacemaker, Model 53401
Reason: A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpe...
Z-2317-2018 July 4, 2018 Mounds View, MN
Philips Electronics North America Corporation
Class II Terminated
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human...
Reason: After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itse...
Z-1589-2018 May 9, 2018 Andover, MA
ConMed Corporation
Class II Terminated
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as ...
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Z-1177-2018 April 4, 2018 Utica, NY
ConMed Corporation
Class II Terminated
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-ster...
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Z-1176-2018 April 4, 2018 Utica, NY
ConMed Corporation
Class II Terminated
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposa...
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Z-1178-2018 April 4, 2018 Utica, NY
ConMed Corporation
Class II Terminated
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-ster...
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Z-1175-2018 April 4, 2018 Utica, NY
ConMed Corporation
Class II Terminated
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-steril...
Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Z-1174-2018 April 4, 2018 Utica, NY