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Philips Electronics North America Corporation

98 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging a recall (Z-3213-2018)Philips Electronics North America Corporation2018-09-21
INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular recall (Z-3214-2018)Philips Electronics North America Corporation2018-09-21
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applica recall (Z-3215-2018)Philips Electronics North America Corporation2018-09-21
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascula recall (Z-3216-2018)Philips Electronics North America Corporation2018-09-21
INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovasc recall (Z-3217-2018)Philips Electronics North America Corporation2018-09-21
INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging appl recall (Z-3218-2018)Philips Electronics North America Corporation2018-09-21
INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular im recall (Z-3219-2018)Philips Electronics North America Corporation2018-09-21
NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular ima recall (Z-3220-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging ap recall (Z-3221-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging ap recall (Z-3222-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular im recall (Z-3223-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular im recall (Z-3224-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging recall (Z-3225-2018)Philips Electronics North America Corporation2018-09-21
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging recall (Z-3226-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging ap recall (Z-3227-2018)Philips Electronics North America Corporation2018-09-21
AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging a recall (Z-3228-2018)Philips Electronics North America Corporation2018-09-21
AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging appl recall (Z-3229-2018)Philips Electronics North America Corporation2018-09-21
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging a recall (Z-3230-2018)Philips Electronics North America Corporation2018-09-21
AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular i recall (Z-3231-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular i recall (Z-3232-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular i recall (Z-3233-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular i recall (Z-3234-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular recall (Z-3235-2018)Philips Electronics North America Corporation2018-09-21
Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurova recall (Z-3236-2018)Philips Electronics North America Corporation2018-09-21
Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular im recall (Z-3237-2018)Philips Electronics North America Corporation2018-09-21
Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascula recall (Z-3238-2018)Philips Electronics North America Corporation2018-09-21
Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular recall (Z-3239-2018)Philips Electronics North America Corporation2018-09-21
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) recall (Z-1430-2018)Philips Electronics North America Corporation2018-04-18
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device recall (Z-1431-2018)Philips Electronics North America Corporation2018-04-18
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for u recall (Z-1432-2018)Philips Electronics North America Corporation2018-04-18
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 7 recall (Z-1433-2018)Philips Electronics North America Corporation2018-04-18
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It ca recall (Z-1434-2018)Philips Electronics North America Corporation2018-04-18
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, recall (Z-1435-2018)Philips Electronics North America Corporation2018-04-18
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use a recall (Z-1436-2018)Philips Electronics North America Corporation2018-04-18
Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic d recall (Z-1437-2018)Philips Electronics North America Corporation2018-04-18
T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce recall (Z-1438-2018)Philips Electronics North America Corporation2018-04-18
ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produc recall (Z-1439-2018)Philips Electronics North America Corporation2018-04-18
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produc recall (Z-1440-2018)Philips Electronics North America Corporation2018-04-18
Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet recall (Z-1441-2018)Philips Electronics North America Corporation2018-04-18
T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cro recall (Z-1442-2018)Philips Electronics North America Corporation2018-04-18
IntelliVue X3 Patient Monitor. recall (Z-1315-2018)Philips Electronics North America Corporation2018-04-06
Philips Network Firewall (Cisco ASA 5506), Model # 867098 recall (Z-0850-2018)Philips Electronics North America Corporation2018-03-03
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V recall (Z-0716-2018)Philips Electronics North America Corporation2018-02-24
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for us recall (Z-0683-2018)Philips Electronics North America Corporation2018-02-22
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for us recall (Z-0684-2018)Philips Electronics North America Corporation2018-02-22
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments recall (Z-0268-2018)Philips Electronics North America Corporation2017-12-20
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 recall (Z-0255-2018)Philips Electronics North America Corporation2017-12-18
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 8 recall (Z-2528-2017)Philips Electronics North America Corporation2017-06-13
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applica recall (Z-0922-2017)Philips Electronics North America Corporation2017-01-20
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applica recall (Z-0923-2017)Philips Electronics North America Corporation2017-01-20
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging ap recall (Z-0924-2017)Philips Electronics North America Corporation2017-01-20
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging recall (Z-0925-2017)Philips Electronics North America Corporation2017-01-20
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neur recall (Z-0825-2017)Philips Electronics North America Corporation2016-12-19
Philips DuraDiagnost stationary X-ray system recall (Z-2682-2016)Philips Electronics North America Corporation2016-09-01
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer fo recall (Z-1316-2016)Philips Electronics North America Corporation2016-04-04
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel w recall (Z-1317-2016)Philips Electronics North America Corporation2016-04-04
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T recall (Z-1024-2016)Philips Electronics North America Corporation2016-02-26
Philips Healthcare IntelliVue Info Center iX, A.0 866023 recall (Z-0856-2016)Philips Electronics North America Corporation2016-02-23
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhy recall (Z-0857-2016)Philips Electronics North America Corporation2016-02-23
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor ( recall (Z-0858-2016)Philips Electronics North America Corporation2016-02-23
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: TH recall (Z-0810-2016)Philips Electronics North America Corporation2016-02-16
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. recall (Z-0764-2016)Philips Electronics North America Corporation2016-02-05
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. recall (Z-0765-2016)Philips Electronics North America Corporation2016-02-05
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 In recall (Z-0702-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and v recall (Z-0703-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and va recall (Z-0704-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging ap recall (Z-0705-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging ap recall (Z-0706-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular recall (Z-0707-2016)Philips Electronics North America Corporation2016-01-30
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to p recall (Z-0708-2016)Philips Electronics North America Corporation2016-01-30
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patien recall (Z-0709-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascul recall (Z-0710-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neuro recall (Z-0711-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neu recall (Z-0712-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging app recall (Z-0713-2016)Philips Electronics North America Corporation2016-01-30
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular im recall (Z-0714-2016)Philips Electronics North America Corporation2016-01-30
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiol recall (Z-0715-2016)Philips Electronics North America Corporation2016-01-30
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physic recall (Z-0716-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended fo recall (Z-0717-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended f recall (Z-0718-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intende recall (Z-0719-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended f recall (Z-0720-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system recall (Z-0721-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended fo recall (Z-0722-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended f recall (Z-0723-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended fo recall (Z-0724-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended f recall (Z-0725-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system recall (Z-0726-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system recall (Z-0727-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 sys recall (Z-0728-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for recall (Z-0729-2016)Philips Electronics North America Corporation2016-01-30
INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is inten recall (Z-0730-2016)Philips Electronics North America Corporation2016-01-30
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer recall (Z-0543-2016)Philips Electronics North America Corporation2015-12-24
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M35 recall (Z-0320-2016)Philips Electronics North America Corporation2015-11-20
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Sy recall (Z-0273-2016)Philips Electronics North America Corporation2015-11-13
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended recall (Z-2328-2015)Philips Electronics North America Corporation2015-08-04
Invivo Expression MRI Patient Monitoring System. recall (Z-2266-2015)Philips Electronics North America Corporation2015-07-27
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001 recall (Z-2200-2015)Philips Electronics North America Corporation2015-07-22

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