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All Recalls

Every Philips Electronics North America Corporation Recall

Sorted by most recent. Click any recall for full details.

99 recalls
CriticalFDA
Philips Electronics North America Corporation
Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 bip...
Medical Devices·6,992 affected·Mar 22, 2017
CriticalFDA
Philips Electronics North America Corporation
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper F...
Medical Devices·6,992 affected·Mar 22, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cros...
Medical Devices·606 affected·Jan 18, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare ...
Medical Devices·156 affected·Jan 17, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Medical Devices·107 affected·Dec 27, 2016
High RiskFDA
Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Medical Devices·59 affected·Dec 9, 2016
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventiona...
Medical Implants·2 affected·Dec 1, 2016
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional pro...
Medical Implants·1 affected·Dec 1, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchang...
Medical Devices·1,824 affected·Sep 19, 2016
CriticalFDA
Philips Electronics North America Corporation
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing ...
Medical Devices·388 affected·Aug 12, 2016
High RiskFDA
Philips Electronics North America Corporation
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need fo...
Medical Devices·50,495 affected·Jul 26, 2016
High RiskFDA
Philips Electronics North America Corporation
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
Diagnostic Devices·993 affected·Jul 19, 2016
High RiskFDA
Philips Electronics North America Corporation
UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10...
Medical Devices·1,536 affected·Jul 7, 2016
High RiskFDA
Philips Electronics North America Corporation
Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 bi...
Medical Devices·1,536 affected·Jul 7, 2016
High RiskFDA
Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibril...
Cardiac Devices·17 affected·Apr 14, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
Medical Devices·1,363 affected·Mar 15, 2016
High RiskFDA
Philips Electronics North America Corporation
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated ...
Medical Devices·539 affected·Feb 10, 2016
High RiskFDA
Philips Electronics North America Corporation
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be sti...
Medical Devices·539 affected·Feb 10, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips IntelliVue Measurement Module X1 Model: M3001A
Medical Devices·13,300 affected·Jan 4, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·5,569 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·1,880 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Medical Devices·5,671 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ra...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnosti...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, includin...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and n...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interve...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic a...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagn...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including dia...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by traine...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnost...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Medical Devices·15 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neuro...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
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 ca...
Medical Implants·196 affected·Oct 1, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine s...
Diagnostic Devices·399 affected·Jul 22, 2015
CriticalFDA
Philips Electronics North America Corporation
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Medical Devices·5,672 affected·Jul 6, 2015
High RiskFDA
Philips Electronics North America Corporation
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-12...
Medical Devices·3,158 affected·Jul 6, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified...
Cardiac Devices·13,168 affected·Jun 5, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Ingenuity Core Computed Tomography X-ray system
Medical Devices·105 affected·Apr 14, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Medical Devices·105 affected·Apr 14, 2015