Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

254 results found for pacemaker Page 9 of 11
Sorin Group USA, Inc.
Class II Terminated
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement...
Reason: Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
Z-0412-2017 November 23, 2016 Arvada, CO
Sorin Group USA, Inc.
Class II Terminated
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measur...
Reason: Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
Z-0413-2017 November 23, 2016 Arvada, CO
Windstone Medical Packaging, Inc.
Class II Terminated
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Z-0256-2017 October 26, 2016 Billings, MT
Boston Scientific Corporation
Class II Terminated
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and tr...
Reason: Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not...
Z-2749-2016 September 14, 2016 Saint Paul, MN
TYRX Inc.
Class II Terminated
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Z-2539-2016 August 24, 2016 Monmouth Junction, NJ
TYRX Inc.
Class II Terminated
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Z-2540-2016 August 24, 2016 Monmouth Junction, NJ
TYRX Inc.
Class II Terminated
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Z-2541-2016 August 24, 2016 Monmouth Junction, NJ
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II Terminated
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2...
Reason: This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting ...
Z-2200-2016 July 20, 2016 Mounds View, MN
Philips Medical Systems, Inc.
Class II Terminated
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper ...
Reason: Loss of key image functionality due to a bent pedal of the Footswitch.
Z-1280-2016 April 6, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including...
Reason: Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Z-1066-2016 March 16, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional pr...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0702-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, c...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0714-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent pl...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0703-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, ...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0707-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, t...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0706-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, t...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0713-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent pla...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0704-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qua...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0715-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventi...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0708-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. pe...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0712-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab techni...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0716-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0710-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, t...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0705-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peri...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0711-2016 February 10, 2016 Andover, MA
Philips Electronics North America Corporation
Class II Terminated
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, int...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0709-2016 February 10, 2016 Andover, MA