FDA Device Recalls

Recalls / Firms / Philips Electronics North America Corporation

Philips Electronics North America Corporation

160 FDA device recalls on record.

DateClassProductReason
2018-11-15Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Number
2018-10-10IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicate
2018-07-16Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imagi
2018-07-16Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applicat
2018-07-16INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging ap
2018-07-16Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging a
2018-07-16INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imagin
2018-07-16Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applicatio
2018-07-16AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications
2018-07-16Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging a
2018-07-16INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular ima
2018-07-16NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging ap
2018-07-16Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applicatio
2018-07-16Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging a
2018-07-16AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging a
2018-07-16Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging ap
2018-07-16AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applicati
2018-07-16AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applicati
2018-07-16Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging
2018-07-16INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applicati
2018-07-16Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging ap
2018-07-16INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging
2018-07-16INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, C
2018-07-16AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applica
2018-07-16INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications
2018-07-16Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging
2018-07-16Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular i
2018-07-16Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applicatio
2018-07-16Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging ap
2018-07-13Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is
2018-07-13Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 8630
2018-07-13Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns
2018-07-13Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital
2018-07-13Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adu
2018-05-03HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated
2018-04-30IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
2018-04-30IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
2018-04-30IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
2018-04-30IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
2018-03-16Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a
2018-03-16Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can
2018-03-16Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3)
2018-03-16T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-se
2018-03-16Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagn
2018-03-16Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva
2018-03-16ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-s
2018-03-16Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It
2018-03-16T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-secti
2018-03-16Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce
2018-03-16T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-s
2018-03-16Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1
2018-03-16Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.
2018-03-14Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional
2018-02-07HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting b
2018-01-29Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with th
2018-01-29Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with th
2018-01-04Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage.
2018-01-03Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 Inte
2017-12-20Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and
2017-12-11digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a par
2017-11-17IntelliVue X3 Patient Monitor.
2017-10-19CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-function
2017-10-05Philips Network Firewall (Cisco ASA 5506), Model # 867098
2017-09-28Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
2017-09-20Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and tran
2017-08-23IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Meas
2017-08-18Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The All
2017-07-17ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables m
2017-07-14Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless
2017-05-31Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0,
2017-05-11Philips DigitalDiagnost 3.1.x X-Ray System
2017-05-04NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
2017-03-22The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura
2017-03-22UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033;
2017-03-22Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD
2017-03-06Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers
2017-01-18Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ra
2017-01-18Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray sy
2017-01-18Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray
2017-01-18Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray syst
2017-01-18Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray syst
2017-01-18Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-r
2017-01-17Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring syste
2016-12-27Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Ce
2016-12-09Velara Generator with an old Firmware version used with the Philips Integris BH5000
2016-12-09Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12
2016-12-01Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications
2016-12-01Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, inc
2016-12-01Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, inc
2016-12-01Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applicati
2016-12-01Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical
2016-09-19Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchang
2016-09-19Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Numbe
2016-09-19Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 8653
2016-08-26HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
2016-08-12PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040
2016-07-26IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care profess
2016-07-19MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
2016-07-19MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
2016-07-19UroDiagnost; x-ray system. Product Code: 708033
2016-07-07Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper
2016-07-07UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029;
2016-04-14HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricula
2016-03-15Philips Healthcare System X-ray Tomography Computed :
2016-03-15Philips Healthcare System X-ray Tomography Computed :
2016-02-10evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when
2016-02-10eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for
2016-01-04Philips IntelliVue Measurement Module X1 Model: M3001A
2016-01-04Philips IntelliVue Module Measurement X2 Model: M3002A
2015-11-25Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Det
2015-11-25Philips Healthcare IntelliVue Info Center iX, A.0 866023
2015-11-25Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arr
2015-11-20Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
2015-11-03INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interv
2015-11-03INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is inten
2015-11-03INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intend
2015-11-03Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging a
2015-11-03INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for int
2015-11-03Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging application
2015-11-03Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular
2015-11-03Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
2015-11-03INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interv
2015-11-03INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interve
2015-11-03Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
2015-11-03Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging application
2015-11-03INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for i
2015-11-03Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging application
2015-11-03Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended f
2015-11-03Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-
2015-11-03INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interv
2015-11-03UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: "
2015-11-03Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X
2015-11-03INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interv
2015-11-03INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interve
2015-11-03INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for intervent
2015-11-03Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists an
2015-11-03INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is in
2015-11-03UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to per
2015-11-03Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascula
2015-11-03Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imagin
2015-11-03Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.
2015-11-03Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging
2015-11-03INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intend
2015-11-03INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interve
2015-10-14Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M353
2015-10-01Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xpe
2015-09-17Philips DuraDiagnost stationary X-ray system
2015-07-22Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination
2015-07-06Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-12
2015-07-06SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR syste
2015-06-17Invivo Expression MRI Patient Monitoring System.
2015-06-05Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use
2015-04-14Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
2015-04-14Philips Healthcare Brilliance 64 Computed Tomography X-ray system
2015-04-14Philips Healthcare Ingenuity CT Computed Tomography X-ray system
2015-04-14Philips Healthcare Ingenuity Core Computed Tomography X-ray system
2015-03-23Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage
2014-11-19ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronize
2014-07-31Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800
2010-12-17M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865