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Philips Medical Systems (Cleveland) Inc

271 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional recall (Z-1655-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional imag recall (Z-1656-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images recall (Z-1657-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) N recall (Z-1607-2015)Philips Medical Systems (Cleveland) Inc2015-05-13
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 recall (Z-1598-2015)Philips Medical Systems (Cleveland) Inc2015-05-12
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brillian recall (Z-1359-2015)Philips Medical Systems (Cleveland) Inc2015-04-01
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model num recall (Z-1011-2015)Philips Medical Systems (Cleveland) Inc2015-01-26
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package P recall (Z-0979-2015)Philips Medical Systems (Cleveland) Inc2015-01-15
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a recall (Z-0190-2015)Philips Medical Systems (Cleveland) Inc2014-12-16
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product c recall (Z-0450-2015)Philips Medical Systems (Cleveland) Inc2014-12-01
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade mod recall (Z-0473-2015)Philips Medical Systems (Cleveland) Inc2014-12-01
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X recall (Z-2711-2014)Philips Medical Systems (Cleveland) Inc2014-09-29
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Comp recall (Z-2709-2014)Philips Medical Systems (Cleveland) Inc2014-09-26
No packaging. The device is a computed tomography scanner. Intended to provide corss secti recall (Z-2678-2014)Philips Medical Systems (Cleveland) Inc2014-09-22
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produ recall (Z-2664-2014)Philips Medical Systems (Cleveland) Inc2014-09-18
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to pr recall (Z-2666-2014)Philips Medical Systems (Cleveland) Inc2014-09-18
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal recall (Z-2237-2014)Philips Medical Systems (Cleveland) Inc2014-08-14
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A dia recall (Z-2037-2014)Philips Medical Systems (Cleveland) Inc2014-07-10
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detect recall (Z-1982-2014)Philips Medical Systems (Cleveland) Inc2014-07-02
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance C recall (Z-1745-2014)Philips Medical Systems (Cleveland) Inc2014-06-22
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT recall (Z-1722-2014)Philips Medical Systems (Cleveland) Inc2014-06-04
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030 recall (Z-1678-2014)Philips Medical Systems (Cleveland) Inc2014-06-02
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic recall (Z-1510-2014)Philips Medical Systems (Cleveland) Inc2014-04-26
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bor recall (Z-1461-2014)Philips Medical Systems (Cleveland) Inc2014-04-16
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland) recall (Z-1464-2014)Philips Medical Systems (Cleveland) Inc2014-04-16
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. recall (Z-1312-2014)Philips Medical Systems (Cleveland), Inc.2014-03-31
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView recall (Z-1074-2014)Philips Medical Systems (Cleveland) Inc2014-02-24
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Clevelan recall (Z-0979-2014)Philips Medical Systems (Cleveland) Inc2014-02-12
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMI recall (Z-0932-2014)Philips Medical Systems (Cleveland) Inc2014-02-04
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 an recall (Z-0791-2014)Philips Medical Systems (Cleveland) Inc2014-01-29
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional recall (Z-0831-2014)Philips Medical Systems (Cleveland) Inc2014-01-27
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, recall (Z-0832-2014)Philips Medical Systems (Cleveland) Inc2014-01-27
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore recall (Z-0801-2014)Philips Medical Systems (Cleveland) Inc2014-01-21
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips recall (Z-0785-2014)Philips Medical Systems (Cleveland) Inc2014-01-17
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Co recall (Z-0335-2014)Philips Medical Systems (Cleveland) Inc2013-11-15
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), o recall (Z-0089-2014)Philips Medical Systems (Cleveland) Inc2013-10-28
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combi recall (Z-0067-2014)Philips Medical Systems (Cleveland) Inc2013-10-25
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama recall (Z-0033-2014)Philips Medical Systems (Cleveland) Inc2013-10-21
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Ai recall (Z-0013-2014)Philips Medical Systems (Cleveland) Inc2013-10-17
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system. recall (Z-0019-2014)Philips Medical Systems (Cleveland) Inc2013-10-17
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & B recall (Z-2210-2013)Philips Medical Systems (Cleveland) Inc2013-09-16
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and recall (Z-1646-2013)Philips Medical Systems (Cleveland) Inc2013-07-02
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole b recall (Z-1588-2013)Philips Medical Systems (Cleveland) Inc2013-06-25
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, C recall (Z-1481-2013)Philips Medical Systems (Cleveland) Inc2013-06-05
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Co recall (Z-1338-2013)Philips Medical Systems (Cleveland) Inc2013-05-20
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal ( recall (Z-1102-2013)Philips Medical Systems (Cleveland) Inc2013-04-12
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography recall (Z-1029-2013)Philips Medical Systems (Cleveland) Inc2013-04-01
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenu recall (Z-0950-2013)Philips Medical Systems (Cleveland) Inc2013-03-14
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v recall (Z-0945-2013)Philips Medical Systems (Cleveland) Inc2013-03-13
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray Syst recall (Z-0906-2013)Philips Medical Systems (Cleveland) Inc2013-03-05
Ingenuity TF PET/CT. Diagnostic imaging system recall (Z-0897-2013)Philips Medical Systems (Cleveland) Inc2013-02-28
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. recall (Z-0899-2013)Philips Medical Systems (Cleveland) Inc2013-02-28
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Syst recall (Z-0786-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Mod recall (Z-0880-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260 recall (Z-0881-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Mode recall (Z-0882-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography ( recall (Z-0883-2013)Philips Medical Systems (Cleveland) Inc2013-02-26
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medica recall (Z-0675-2013)Philips Medical Systems (Cleveland) Inc2013-01-16
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - recall (Z-0674-2013)Philips Medical Systems (Cleveland) Inc2013-01-15
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Phili recall (Z-0479-2013)Philips Medical Systems (Cleveland) Inc2012-12-21
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchbu recall (Z-0206-2013)Philips Medical Systems (Cleveland), Inc.2012-11-05
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMIN recall (Z-2451-2012)Philips Medical Systems (Cleveland) Inc2012-09-25
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomo recall (Z-2404-2012)Philips Medical Systems (Cleveland) Inc2012-09-19
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System recall (Z-2386-2012)Philips Medical Systems (Cleveland) Inc2012-09-14
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEM recall (Z-2239-2012)Philips Medical Systems (Cleveland) Inc2012-08-22
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems The recall (Z-2245-2012)Philips Medical Systems (Cleveland) Inc2012-08-22
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intend recall (Z-2223-2012)Philips Medical Systems (Cleveland) Inc2012-08-17
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray S recall (Z-2035-2012)Philips Medical Systems (Cleveland) Inc2012-07-19
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-cl recall (Z-2000-2012)Philips Medical Systems (Cleveland) Inc2012-07-12
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal recall (Z-1987-2012)Philips Medical Systems (Cleveland) Inc2012-07-11
Intellispace Portal software. Intellispace Portal is a multimodality thin client applicati recall (Z-1988-2012)Philips Medical Systems (Cleveland) Inc2012-07-11
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cr recall (Z-1791-2012)Philips Medical Systems (Cleveland) Inc2012-06-08
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cr recall (Z-1688-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction Product recall (Z-1690-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #72 recall (Z-1691-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall (Z-1692-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System recall (Z-1693-2012)Philips Medical Systems (Cleveland) Inc2012-05-30
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagn recall (Z-1646-2012)Philips Medical Systems (Cleveland) Inc2012-05-22
Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: recall (Z-1366-2012)Philips Medical Systems (Cleveland) Inc2012-04-05
Extended Brilliance Workstation Computed Tomography X-Ray Systems, M/N 728260, Distributed recall (Z-1367-2012)Philips Medical Systems (Cleveland) Inc2012-04-05
GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Dist recall (Z-1368-2012)Philips Medical Systems (Cleveland) Inc2012-04-05
GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476 recall (Z-1369-2012)Philips Medical Systems (Cleveland) Inc2012-04-05
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model# 728 recall (Z-1361-2012)Philips Medical Systems (Cleveland) Inc2012-04-02
IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and recall (Z-1337-2012)Philips Medical Systems (Cleveland) Inc2012-03-30
Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 6 recall (Z-1285-2012)Philips Medical Systems (Cleveland) Inc2012-03-23
The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray S recall (Z-1219-2012)Philips Medical Systems (Cleveland) Inc2012-03-16
TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #45980011166 recall (Z-1056-2012)Philips Medical Systems (Cleveland) Inc2012-02-17
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers recall (Z-1046-2012)Philips Medical Systems (Cleveland) Inc2012-02-16
Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX recall (Z-0988-2012)Philips Medical Systems (Cleveland) Inc2012-02-10
Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomograph recall (Z-0946-2012)Philips Medical Systems (Cleveland) Inc2012-02-03
GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Clevelan recall (Z-0937-2012)Philips Medical Systems (Cleveland) Inc2012-02-02
Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bor recall (Z-0845-2012)Philips Medical Systems (Cleveland) Inc2012-01-24
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEM recall (Z-0805-2012)Philips Medical Systems (Cleveland) Inc2012-01-18
Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Seri recall (Z-0777-2012)Philips Medical Systems (Cleveland) Inc2012-01-17
Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Num recall (Z-0778-2012)Philips Medical Systems (Cleveland) Inc2012-01-17
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers recall (Z-0779-2012)Philips Medical Systems (Cleveland) Inc2012-01-17
Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453 recall (Z-0594-2012)Philips Medical Systems (Cleveland), Inc.2012-01-11
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers recall (Z-0693-2012)Philips Medical Systems (Cleveland) Inc2012-01-11
Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: recall (Z-0360-2012)Philips Medical Systems (Cleveland) Inc2011-12-02
Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: recall (Z-0361-2012)Philips Medical Systems (Cleveland) Inc2011-12-02
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