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Philips Medical Systems (Cleveland) Inc

271 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 72824 recall (Z-0334-2012)Philips Medical Systems (Cleveland) Inc2011-12-01
Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Ser recall (Z-0335-2012)Philips Medical Systems (Cleveland) Inc2011-12-01
Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units recall (Z-0343-2012)Philips Medical Systems (Cleveland) Inc2011-12-01
Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) recall (Z-0344-2012)Philips Medical Systems (Cleveland) Inc2011-12-01
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. Syst recall (Z-0293-2012)Philips Medical Systems (Cleveland) Inc2011-11-28
Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brillianc recall (Z-3281-2011)Philips Medical Systems (Cleveland) Inc2011-09-27
Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial N recall (Z-3208-2011)Philips Medical Systems (Cleveland) Inc2011-09-14
Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Seria recall (Z-3209-2011)Philips Medical Systems (Cleveland) Inc2011-09-14
Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Ser recall (Z-3199-2011)Philips Medical Systems (Cleveland) Inc2011-09-13
Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Ser recall (Z-3200-2011)Philips Medical Systems (Cleveland) Inc2011-09-13
Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) # recall (Z-3201-2011)Philips Medical Systems (Cleveland) Inc2011-09-13
Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomograph recall (Z-2914-2011)Philips Medical Systems (Cleveland) Inc2011-08-01
GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 90 recall (Z-2915-2011)Philips Medical Systems (Cleveland) Inc2011-08-01
Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, recall (Z-2205-2011)Philips Medical Systems (Cleveland) Inc2011-05-19
Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, includi recall (Z-2206-2011)Philips Medical Systems (Cleveland) Inc2011-05-19
Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subj recall (Z-2207-2011)Philips Medical Systems (Cleveland) Inc2011-05-19
MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E98 recall (Z-2059-2011)Philips Medical Systems (Cleveland) Inc2011-04-26
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System recall (Z-1819-2011)Philips Medical Systems (Cleveland) Inc2011-03-24
Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray Syste recall (Z-1820-2011)Philips Medical Systems (Cleveland) Inc2011-03-24
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands an recall (Z-1669-2011)Philips Medical Systems (Cleveland) Inc2011-03-16
Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3 recall (Z-0133-2011)Philips Medical Systems (Cleveland) Inc2010-10-22
Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Bri recall (Z-2460-2010)Philips Medical Systems (Cleveland) Inc2010-09-22
MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended recall (Z-0780-2010)Philips Medical Systems (Cleveland) Inc2010-02-19
Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmon recall (Z-0286-2010)Philips Medical Systems (Cleveland) Inc2009-11-17
Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the followi recall (Z-0287-2010)Philips Medical Systems (Cleveland) Inc2009-11-17
GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanni recall (Z-0260-2010)Philips Medical Systems (Cleveland) Inc2009-11-13
GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice co recall (Z-0261-2010)Philips Medical Systems (Cleveland) Inc2009-11-13
TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstat recall (Z-1542-2009)Philips Medical Systems (Cleveland) Inc2009-07-13
Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #4550112026 recall (Z-1568-2009)Philips Medical Systems (Cleveland) Inc2009-07-06
TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on recall (Z-1578-2009)Philips Medical Systems (Cleveland) Inc2009-07-06
TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an recall (Z-1579-2009)Philips Medical Systems (Cleveland) Inc2009-07-06
TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011 recall (Z-1580-2009)Philips Medical Systems (Cleveland) Inc2009-07-06
Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX ser recall (Z-0597-2009)Philips Medical Systems (Cleveland) Inc2009-01-16
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Too recall (Z-0132-2009)Philips Medical Systems (Cleveland) Inc2008-10-28
Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 441 recall (Z-1510-2008)Philips Medical Systems (Cleveland) Inc2008-09-19
Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 441 recall (Z-1511-2008)Philips Medical Systems (Cleveland) Inc2008-09-19
Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System, Cl recall (Z-1512-8)Philips Medical Systems (Cleveland) Inc2008-09-19
Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging system recall (Z-0461-2008)Philips Medical Systems (Cleveland) Inc2008-01-31
Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging s recall (Z-0462-2008)Philips Medical Systems (Cleveland) Inc2008-01-31
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on al recall (Z-0366-2008)Philips Medical Systems (Cleveland) Inc2007-12-29
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on al recall (Z-0367-2008)Philips Medical Systems (Cleveland) Inc2007-12-29
Philips, Voxel Q workstations, untilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4 recall (Z-0180-2008)Philips Medical Systems (Cleveland) Inc2007-11-21
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfuncti recall (Z-0121-2008)Philips Medical Systems (Cleveland) Inc2007-11-07
Brilliance CT Systems, 40 slice configuration. Computed tomography scanner. recall (Z-0110-2008)Philips Medical Systems (Cleveland) Inc2007-10-31
Brilliance CT Systems 64 slice configuration. Computed tomography scanner. recall (Z-0111-2008)Philips Medical Systems (Cleveland) Inc2007-10-31
Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 7 recall (Z-0013-2007)Philips Medical Systems (Cleveland) Inc2007-09-26
Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 recall (Z-0014-2007)Philips Medical Systems (Cleveland) Inc2007-09-26
The product is an isolation transformer, an accessory to Computed Tomography Scanner. It c recall (Z-1234-2007)Philips Medical Systems (Cleveland) Inc2007-09-13
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) recall (Z-0636-2007)Philips Medical Systems (Cleveland) Inc2007-03-17
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and p recall (Z-0889-06)Philips Medical Systems (Cleveland) Inc2006-05-19
Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer n recall (Z-0068-06)Philips Medical Systems (Cleveland) Inc2005-10-21
Brilliance CT System, 40 channel configuration using version 1.2 software. recall (Z-1409-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software. recall (Z-1410-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Brillance 16, 10, and 6 configuration (watercooled version) using 1.0, 1.1, 1.2, 1.2.2, or recall (Z-1411-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Brillance CT System, 16, 10 and 6 configurations (air cooled version) using version 1.2 or recall (Z-1412-05)Philips Medical Systems (Cleveland) Inc2005-08-30
MX8000IDT CT Scanner using version 2.5.5, 3.0, 3.1, 3.2, 3.2.2, or 3.2.4 software. recall (Z-1413-05)Philips Medical Systems (Cleveland) Inc2005-08-30
MX8000 Dual v.EXP CT scanner using Version 2.5 software. recall (Z-1414-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Extended Brilliance Workspace using 1.x or 2.x software. recall (Z-1415-05)Philips Medical Systems (Cleveland) Inc2005-08-30
MxView using version 5.0, 5.0.1, or 4.1 software. recall (Z-1416-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Gemini PET/CT sytem, Dual Configuration recall (Z-1417-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Gemini 16 PET/CT sytem, Slice Configuration recall (Z-1418-05)Philips Medical Systems (Cleveland) Inc2005-08-30
Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand na recall (Z-0957-05)Philips Medical Systems (Cleveland) Inc2005-07-06
AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: recall (Z-0958-05)Philips Medical Systems (Cleveland) Inc2005-07-06
Intinion 1.5 T MRI Scanner. recall (Z-0272-05)Philips Medical Systems (Cleveland) Inc2004-12-02
Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. recall (Z-0786-04)Philips Medical Systems (Cleveland) Inc2004-07-20
Philips Brilliance CT Scanner System, 6, 10 & 16 slice images. recall (Z-0787-04)Philips Medical Systems (Cleveland) Inc2004-07-20
Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. recall (Z-0093-04)Philips Medical Systems (Cleveland) Inc2003-11-06
Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. recall (Z-0094-04)Philips Medical Systems (Cleveland) Inc2003-11-06
Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. recall (Z-0095-04)Philips Medical Systems (Cleveland) Inc2003-11-06
Philips MX8000 IDT CT Scanner, utilizing V2.1 software. recall (Z-0835-03)Philips Medical Systems (Cleveland) Inc2003-05-15
Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. recall (Z-0836-03)Philips Medical Systems (Cleveland) Inc2003-05-15
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