Philips Electronics North America Corporation
106 recalls on record · Latest: Dec 26, 2018
FDA Devices Moderate Jun 21, 2017
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 8650…
FDA Devices Moderate Jun 21, 2017
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Pro…
FDA Devices Moderate Jun 7, 2017
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
FDA Devices Moderate Apr 26, 2017
Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029;…
FDA Devices Moderate Apr 26, 2017
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 7…
FDA Devices Moderate Mar 1, 2017
Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professional…
FDA Devices Moderate Feb 1, 2017
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures…
FDA Devices Moderate Feb 1, 2017
Velara Generator with an old Firmware version used with the Philips Integris BH5000
FDA Devices Moderate Feb 1, 2017
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
FDA Devices Moderate Feb 1, 2017
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (suc…
FDA Devices Moderate Dec 28, 2016
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with …
FDA Devices Moderate Nov 30, 2016
Philips Healthcare System X-ray Tomography Computed :
FDA Devices Moderate Oct 26, 2016
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453…
FDA Devices Moderate Oct 26, 2016
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564…
FDA Devices Moderate Sep 7, 2016
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Comp…
FDA Devices Moderate Sep 7, 2016
UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table…
FDA Devices Moderate Sep 7, 2016
Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 7220…
FDA Devices Moderate Aug 10, 2016
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring…
FDA Devices Moderate Aug 10, 2016
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
FDA Devices Moderate May 11, 2016
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The …
FDA Devices Moderate Apr 13, 2016
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infan…
FDA Devices Moderate Apr 13, 2016
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in t…
FDA Devices Moderate Mar 16, 2016
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…
FDA Devices Moderate Mar 9, 2016
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
FDA Devices Moderate Mar 2, 2016
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
FDA Devices Moderate Mar 2, 2016
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
FDA Devices Moderate Mar 2, 2016
Philips Healthcare IntelliVue Info Center iX, A.0 866023
FDA Devices Moderate Mar 2, 2016
Philips IntelliVue Measurement Module X1 Model: M3001A
FDA Devices Moderate Feb 24, 2016
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with …
FDA Devices Moderate Feb 17, 2016
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diag…
FDA Devices Moderate Feb 17, 2016
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
FDA Devices Moderate Feb 10, 2016
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging ap…
FDA Devices Moderate Feb 10, 2016
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular a…
FDA Devices Moderate Feb 10, 2016
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic…
FDA Devices Moderate Feb 10, 2016
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular…
FDA Devices Moderate Feb 10, 2016
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional proc…
FDA Devices Moderate Feb 10, 2016
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and intervent…
FDA Devices Moderate Feb 10, 2016
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascul…
FDA Devices Moderate Feb 10, 2016
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic,…
FDA Devices Moderate Feb 10, 2016
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascul…
FDA Devices Moderate Feb 10, 2016
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and …
FDA Devices Moderate Feb 10, 2016
INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…
FDA Devices Moderate Feb 10, 2016
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…
FDA Devices Moderate Feb 10, 2016
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…
FDA Devices Moderate Feb 10, 2016
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital s…
FDA Devices Moderate Feb 10, 2016
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular …
FDA Devices Moderate Feb 10, 2016
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascul…
FDA Devices Moderate Feb 10, 2016
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurova…
FDA Devices Moderate Feb 10, 2016
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular ima…
FDA Devices Moderate Feb 10, 2016