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Credits
Manufacturers
Philips Medical Systems North America Co. Phillips
Manufacturer Address
Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
Source
USFDA
127 Events
Recall of Interis Allura BiPlane X-Ray System
Recall of Device Recall System, Nuclear Magnetic Resonance Imaging
Recall of Device Recall Allura Xper FD10
Recall of Device Recall Allura Xper FD10/10
Recall of Device Recall EasyVision
Recall of Device Recall Allura Xper FD 10/10
Recall of Device Recall Allura Xper FD 10
Recall of Device Recall Integris Allura
Recall of Device Recall Integris Allura
Recall of Device Recall Integris Allura
Recall of Device Recall Integris Allura
Recall of Device Recall Integris Allura
Recall of Device Recall Integris Allura
Recall of View Forum 2003 software, SW 3.4L1
Recall of MD3
Recall of MD 4
Recall of Gyroscan
Recall of Intera
Recall of Achieva
Recall of Panorama 1.0T
Recall of Allura Xper
Recall of Allura Xper FD20/10
Recall of Intera 1.5T and 1.5T Achieva MRI systems
Recall of NEUVIZ DUAL MULTISLICE CT SCANNER SYSTEM
Recall of Essenta DR Xray system
Recall of PercuNav Field Generator Stand
Recall of Device Recall PercuNav, Tool Connection Unit
Recall of Device Recall Philips HeartStart FRx 861304 Automated External Defibrillator
Recall of Device Recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family
Recall of Device Recall Philips Automatic Collimator or Beam Limiting Device
Recall of Device Recall Practix 33 Plus
Recall of Device Recall Practix 160
Recall of Device Recall Practix 300
Recall of Device Recall BV Pulsera
Recall of Device Recall Phillips Endura XRay Systems
Recall of Device Recall Bucky Diagnost
Recall of Device Recall Digital Diagnost
Recall of Device Recall Easy Diagnost
Recall of Device Recall Easy Diagnost Eleva
Recall of Device Recall Omni Diagnost Eleva
Recall of Device Recall Multi Diagnost Eleva
Recall of Device Recall Philips MutliDiagnost Eleva FD
Recall of Device Recall Diagnost 56/66/76/76 Plus
Recall of Device Recall EasyDiagnost Classic
Recall of Device Recall EasyDiagnost DSI
Recall of Device Recall DigitalDiagnost Xray system
Recall of Device Recall AD 7 Patient table
Recall of Device Recall General XRay System types with Digital Spot Imaging (DSI)
Recall of Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems
Recall of Device Recall EasyDiagnost Eleva
Recall of Device Recall Allura Xper FD10
Recall of Device Recall Allura Xper FD10
Recall of Device Recall Philips IntelliVue Information Center
Recall of Device Recall Allura XPER 10/10
Recall of Device Recall Integris H5000F
Recall of Device Recall Integris BH5000
Recall of Device Recall Integris XPER FD10 F/C
Recall of Device Recall Allura XPER FD20/10
Recall of Device Recall Allura XPER FD20
Recall of Device Recall Integris Allura Flat Detector 9C
Recall of Device Recall MultiDiagnost Eleva
Recall of Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)
Recall of Device Recall OminDiagnost Eleva
Recall of Device Recall EasyDiagnost Eleva xray systems
Recall of Device Recall ACHIEVA 1.5T and INTERA 1.5T Nuclear Magnetic Resonance Imaging
Recall of Device Recall Philips Easy Diagnost Eleva Conventional R/F system
Recall of Device Recall Philips EasyVision MM workstation with software
Recall of Device Recall EasyDiagnost
Recall of Device Recall Easy Diagnost Digital
Recall of Device Recall LithoDiagnost
Recall of Device Recall UroDiagnost
Recall of Device Recall MultiDiagnost MD3
Recall of Device Recall MultiDiagnost MD4
Recall of Device Recall OmniDiagnost
Recall of Device Recall Diagnost 96/97 DSI
Recall of Device Recall Diagnost 76
Recall of Device Recall DigitalDiagnost
Recall of Device Recall BuckyDiagnost
Recall of Device Recall EasyDiagnost
Recall of Device Recall MONOPLANE Xray Imaging Systems with Velara Generator
Recall of Device Recall BIPLANE XRay Imaging Systems with Velara Generator
Recall of Device Recall Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system
Recall of Device Recall MultiDiagnost Eleva with FD
Recall of Device Recall Allura XPER
Recall of Device Recall Allura XPER FD10 F/C
Recall of Device Recall ALLURA XPER FD10/10
Recall of Device Recall ALLURA XPER FD20
Recall of Device Recall ALLURA XPER FD20/10
Recall of Device Recall Philips Healthcare Allura XPER FD10
Recall of Device Recall Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system
Recall of Device Recall Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system
Recall of Device Recall ACHIEVA 3.0T and Panorama 1T
Recall of Device Recall PCR Eleva
Recall of Device Recall Panorama HFO
Recall of Device Recall Philips BV Libra
Recall of Device Recall Philips BV Endura
Recall of Device Recall Philips BV Pulsera
Recall of Device Recall Philips Healthcare Allura XPER FD20
Recall of AD5 table for use with Integris and Integris Allura x-ray systems
Recall of AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
Recall of AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems.
Recall of AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.
Recall of Allura
Recall of Allura
Recall of Allura Integris Systems with OMCP Generator
Recall of Edge 1.5T MRI
Recall of Vista MRI System
Recall of Eclipse 1.5T MRI
Recall of Vista Polaris 1.0T MRI
Recall of Infinion 1.5T MRI
Recall of Panorama 0.6T Open MR system
Recall of BV Pulsera R2.2 Mobile Xray system
Recall of BV Endura R2.2 Mobile Xray system
Recall of BV Pulsera Rel 2
Recall of BV Endura Rel 2
Recall of Allura XPER 10/10
Recall of Integris H5000F
Recall of Integris BH5000
Recall of Integris XPER FD10 F/C
Recall of Allura XPER FD20/10
Recall of Allura XPER FD20
Recall of Integris Allura Flat Detector 9C
Recall of BABIX Holder for BuckyDiagnost Xray system
Recall of BABIX holder for DigitalDiagnost Xray system
Recall of Allura Xper Systems with Velara Generator
Recall of MultiDiagnost Eleva
Recall of OmniDiagnost Eleva
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123 devices in the database
Interis Allura BiPlane X-Ray System
Model / Serial
The firm utilizes site numbers: 520582, 531926, 535761, 535775, 520949, 530660, 530654, 522136, 521325, 532241, 531939, 520721, 104949, 530396, 532152, 530653, 532383, 531649, 534756, 533290, 521525, 533397, 534786, 520688, 522456, 520964, 532218, 521149, 520275, 532240, 531758, 520666, 519196, 531799, 519981, 520756, 76992, 534131, 506509, 519197, 533288, 537175, 537181
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Devices were distributed to hospitals/medical centers nationwide.
Product Description
Interis Allura BiPlane X-Ray System
Device Recall System, Nuclear Magnetic Resonance Imaging
Model / Serial
4397, 5257, 4176, 1052, 4222, 4064, 5024, 4009, 4241, 5313, 1139, 5484, 4328, 5201, 5246, 5381, 4296, 4258, 5277, 4246, 1240, 5297, 5311, 5434, 5512, 506, 4207, 1072, 4089, 5373, 1014, 1078, 4025, 5551, 4131, 5455, 5328, 5379, 5261, 4416, 4206, 1191, 4088, 5195, 5334, 5451, 4383, 5250, 5309, 5342, 4183, 4272, 5268, 5009, 4047, 4254, 4261, 5307, 4102, 5199, 5558, 5315, 5266, 5303, 1061, 4307, 5390, 4267, 4386, 5282, 1113, 5123, 5501, 1062, 4339, 5383, 5478, 5507, 4162, 1015, 5162, 1081, 4170, 5477, 4322, 5515, 4069, 5081, 4201, 354, 5345, 4374, 4146, 1097, 5519, 5314
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
96 units distributed to 92 U.S. Customers
Product Description
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
Device Recall Allura Xper FD10
Model / Serial
site numbers provided with the Allura Xper FD10/10
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.
Product Description
Allura Xper FD10 x-ray system
Device Recall Allura Xper FD10/10
Model / Serial
Site numbers 533762, 534634, 535667, 534678, 532799, 532800, 539107, 537630, 534638, 533278, 533282, 533283, 538514, 540016, 538744, 538485, 538486, 535415, 538028, 532614, 533476, 538409, 536789, 538516, 532611, 538157, 538368, 536715, 534731, 540841, 537804, 522138, 538903, 538476, 536899, 536028, 540237, 530666, 530667, 533619, 537698, 539628, 541276, 537745, 531942, 542113, 542117, 536138, 533289, 536031, 536034, 536035, 536037, 536042, 540234
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.
Product Description
Allura Xper FD10/10 x-ray system
Device Recall EasyVision
Model / Serial
PACS EasyVision / EasyAccess Release 10.1/10.2 Site numbers 542691, 105592, 519705, 100640, 541132, 530547, 76937, 105094, 505455, 85176, 105803, 105806, 505284, 13928, 105176, 505609, 536655, 86261, 105090, 101590, 105419, 84402, 505625, 104599, 505829, 532250, 105105, 103767, 532248, 541162, 85052, 532200, 20920024, 105257, 532654, 532642, 533323, 86050, 506259, 533223, 538795, 105106, 505267, 104946, 538798, 84026, 84033, 83937, 538801, 103513, 105374, 506328, 536253, 542386, 533622, 538484, 104551, 103066, 537982, 505674, 530752, 506046, 85173, 100592, 505623, 101168, 506700, 506367, 532390, 519811, 541133, 540768, 84083, 101378, 104982, 103096, 506265, 530448, 536658, 521136, 535317, 506000, 105026, 105067, 105043, 506505, 84896, 84873, 532946, 506461, 539156, 105604, 506122, 505973, 533999, 532691, 531852, 534508, 505388, 102155, 521761, 519977, 540771, 533268, 505001, 505183, 86345, 45053, 530661, 105021, 101356, 103220, 520416, 102594, 505065, 520458, 103340, 105931, 532583, 521516, 105765, 505796, 542077, 520442, 506228, 530805, 105599, 86457, 530553, 103715, 504825, 534766, 521200, 540249, 506001, 105517, 530555, 84967, 505897, 505898, 86198, 506161, 506226, 538802, 533720, 84866, 101033, 10381, 505427, 101419, 530518, 519965, 532368, 506707, 102076, 505044, 519629
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option
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