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Philips Medical Systems (Cleveland) Inc

271 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Mode recall (Z-2570-2025)Philips Medical Systems (Cleveland) Inc2025-09-16
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software recall (Z-2239-2025)Philips Medical Systems (Cleveland) Inc2025-08-01
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. recall (Z-1744-2022)Philips Medical Systems (Cleveland) Inc2022-09-15
Forte Gamma Camera System is intended to produce images depicting the anatomical distribut recall (Z-0213-2020)Philips Medical Systems (Cleveland) Inc2019-11-01
Forte Gamma Camera System is intended to produce images depicting the anatomical distribut recall (Z-0214-2020)Philips Medical Systems (Cleveland) Inc2019-11-01
Forte Gamma Camera System is intended to produce images depicting the anatomical distribut recall (Z-0215-2020)Philips Medical Systems (Cleveland) Inc2019-11-01
Forte Gamma Camera System is intended to produce images depicting the anatomical distribut recall (Z-0216-2020)Philips Medical Systems (Cleveland) Inc2019-11-01
Forte Gamma Camera System is intended to produce images depicting the anatomical distribut recall (Z-0217-2020)Philips Medical Systems (Cleveland) Inc2019-11-01
Ingenuity CT, Model # 728326, computed tomography x-ray system recall (Z-2186-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
Ingenuity Core128 Model # 728323, computed tomography x-ray system recall (Z-2187-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
Ingenuity Core Model # 728321, computed tomography x-ray system recall (Z-2188-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
iCT, Model # 728306, computed tomography x-ray system recall (Z-2189-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
iCT SP Model # 728311, computed tomography x-ray system recall (Z-2190-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
Brilliance 64 Model # 728231, computed tomography x-ray system recall (Z-2191-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
IQon Spectral CT Model # 728332, computed tomography x-ray system recall (Z-2192-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system recall (Z-2193-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
Vereos PET/CT Model # 882446, computed tomography x-ray system recall (Z-2194-2019)Philips Medical Systems (Cleveland) Inc2019-08-06
BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras d recall (Z-0510-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Pho recall (Z-0511-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras desig recall (Z-0512-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging s recall (Z-0513-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging recall (Z-0514-2018)Philips Medical Systems (Cleveland) Inc2018-02-03
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designe recall (Z-1750-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed recall (Z-1751-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designe recall (Z-1752-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designe recall (Z-1753-2017)Philips Medical Systems (Cleveland) Inc2017-04-06
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual det recall (Z-1479-2017)Philips Medical Systems (Cleveland) Inc2017-03-16
882480: BrightView designed for single or dual detector nuclear imaging accommodating a ra recall (Z-1480-2017)Philips Medical Systems (Cleveland) Inc2017-03-16
882478: BrightView X designed for single or dual detector nuclear imaging accommodating a recall (Z-1481-2017)Philips Medical Systems (Cleveland) Inc2017-03-16
Brilliance 64 Computed Tomography X-ray system recall (Z-0544-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Brilliance iCT Computed Tomography X-ray system recall (Z-0545-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Brilliance iCT SP Computed Tomography X-ray system recall (Z-0546-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Ingenuity Core Computed Tomography X-ray system recall (Z-0547-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Ingenuity Core 128 Computed Tomography X-ray system recall (Z-0548-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Ingenuity CT Computed Tomography X-ray system recall (Z-0549-2016)Philips Medical Systems (Cleveland) Inc2015-12-24
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. recall (Z-0400-2016)Philips Medical Systems (Cleveland) Inc2015-12-10
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0 recall (Z-0409-2016)Philips Medical Systems (Cleveland) Inc2015-12-10
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that c recall (Z-0197-2016)Philips Medical Systems (Cleveland) Inc2015-11-02
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems recall (Z-2491-2015)Philips Medical Systems (Cleveland) Inc2015-08-31
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intend recall (Z-2254-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to p recall (Z-2255-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional i recall (Z-2256-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional imag recall (Z-2257-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional recall (Z-2258-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-section recall (Z-2259-2015)Philips Medical Systems (Cleveland) Inc2015-07-24
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family recall (Z-2193-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integr recall (Z-2194-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family o recall (Z-2195-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family o recall (Z-2196-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of i recall (Z-2197-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of in recall (Z-2198-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family o recall (Z-2199-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to pro recall (Z-2203-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to recall (Z-2204-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems recall (Z-2205-2015)Philips Medical Systems (Cleveland) Inc2015-07-22
MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-r recall (Z-1759-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomog recall (Z-1760-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) acce recall (Z-1761-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1762-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed T recall (Z-1763-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Co recall (Z-1764-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1765-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1766-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Com recall (Z-1767-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1768-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray sy recall (Z-1769-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1770-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1771-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra recall (Z-1772-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1773-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray sys recall (Z-1774-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray syst recall (Z-1775-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed To recall (Z-1776-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra recall (Z-1777-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X recall (Z-1778-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1779-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograph recall (Z-1780-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr recall (Z-1781-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr recall (Z-1782-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Co recall (Z-1783-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1784-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1785-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1786-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed recall (Z-1787-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1788-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra recall (Z-1789-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1790-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograph recall (Z-1791-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography recall (Z-1792-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Com recall (Z-1793-2015)Philips Medical Systems (Cleveland) Inc2015-06-11
Brilliance iCT Computed Tomography X-ray system recall (Z-1695-2015)Philips Medical Systems (Cleveland) Inc2015-05-29
Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 8823 recall (Z-1682-2015)Philips Medical Systems (Cleveland) Inc2015-05-28
MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sec recall (Z-1647-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cro recall (Z-1648-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional im recall (Z-1649-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional im recall (Z-1650-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectio recall (Z-1651-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectio recall (Z-1652-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectiona recall (Z-1653-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectiona recall (Z-1654-2015)Philips Medical Systems (Cleveland) Inc2015-05-22
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