Philips Medical Systems (Cleveland), Inc.
Philips Medical Systems (Cleveland), Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2017, with 315 FDA device recalls on record.
Top product codes for Philips Medical Systems (Cleveland), Inc.
FDA recalls by Philips Medical Systems (Cleveland), Inc.
10 most recent of 315- Z-2570-2025 — Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.
- Z-2239-2025 — Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Z-1744-2022 — Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
- Z-0215-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-0214-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-0217-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-0216-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-0213-2020 — Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Z-2194-2019 — Vereos PET/CT Model # 882446, computed tomography x-ray system
- Z-2190-2019 — iCT SP Model # 728311, computed tomography x-ray system
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Medical Systems (Cleveland), Inc.
1–100 of 190- K171850 — Philips CT Big Bore
- K172406 — Ingenuity TF
- K162838 — Philips iCT CT System
- K163711 — IQon Spectral CT
- K170086 — Pinnacle Radiation Therapy Planning System
- K160743 — Philips Ingenuity CT
- K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer
- K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
- K111336 — EBW NM 2.0
- K111024 — JETPACK 2.0
- K092747 — PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
- K090462 — BRILLIANCE DUAL ENERGY OPTION
- K091195 — PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
- K090403 — AUTOSPECT
- K083498 — PHILIPS MODEL MX 16 SLICE CT SYSTEM
- K081426 — NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
- K081135 — GEMINI CONDOR
- K080927 — BRIGHTVIEW VCT IMAGING SYSTEM
- K060937 — BRILLIANCE VOLUME
- K052640 — GEMINI RAPTOR
- K051170 — GEMINI GXL
- K042935 — GEMINI GXL
- K042839 — C-PET PLUS IMAGING SYSTEM
- K042293 — BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
- K041955 — GEMINI PET/CT IMAGING SYSTEM
- K033677 — BRAIN PERFUSION OPTION
- K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271
- K033782 — ALLEGRO IMAGING SYSTEM
- K032036 — GEMINI 16
- K031095 — SENSE BODY COIL
- K023785 — LUNG NODULE ASSESSMENT AND COMPARISON OPTION
- K024066 — INFINION SOFTWARE FEATURES
- K013858 — INFINION 0.6T MR IMAGING SYSTEM
- K011296 — INFINION ENHANCEMENT PACKAGE
- K010817 — MX8000 V5.0 CT SYSTEM
- K010691 — BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
- K003853 — INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
- K003437 — ODYSSEY LX, MODEL 211320
- K002415 — POWERDRIVE 350 OPTION
- K001088 — ULTRASIM CT SYSTEM
- K000310 — VOYAGER 6.0 SOFTWARE OPTION
- K991256 — VIEWPOINT ENT/ORTHOPEDIC OPTION
- K992335 — BEACON-P, MODEL 211059
- K992225 — QUANTITATIVE FLOW
- K991943 — MRGP OPTICAL TRACKING UNIT
- K992412 — IPASS BOLUS TRACKING
- K991568 — MR SPECTROSCOPY PACKAGE
- K983764 — VIEWPOINT TOOLS- STERRAD
- K983948 — BEACON, MODEL 211060
- K990860 — VIEWPOINT MICROSCOPE OPTION
- K990868 — VIEWPOINT PASSIVE TOOL OPTION
- K984588 — PHASED ARRAY FLEXIBLE CARDIAC COIL
- K984401 — NEUROMAG VECTORVIEW
- K983342 — MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
- K984111 — FV-RF
- K982010 — FACTS
- K974770 — ACQPLAN
- K980831 — IMAGE POST-PROCESSING TECHNIQUES
- K981959 — OUTLOOK LARGE PHASED ARRAY NECK COIL
- K981406 — CERVIX COIL LATEX SHEATH
- K981410 — HAMMERSMITH ENDOCAVITARY COILS
- K980918 — JPACS
- K974513 — PINPOINT
- K974844 — OUTLOOK SYSTEM ENHANCEMENT PACKAGE
- K974530 — DUFFUSION-WEIGHTED MR IMAGING PACKAGE
- K971884 — ASSET APOLLO
- K970604 — VIEWPOINT - 3.0 SOFTWARE
- K962010 — EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
- K963406 — UHE COLLIMATOR (210591)
- K964752 — KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
- K964712 — PRISM XPVT SYSTEM (210823)
- K964678 — PHASED ARRAY NECK COIL
- K964626 — EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
- K963221 — OPTICAL DIGITIZER OPTION FOR VIEW POINT
- K963356 — PHASED ARRAY SHOULDER COIL
- K962764 — NEUROMAG-122
- K960865 — STEP OPTION TO PRISM 2000
- K960192 — POSITRON COINCIDENCE DETECTION
- K962117 — QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
- K961577 — PRISM 3000XPV SYSTEM (210714)
- K960497 — FLEXIBLE PHASED ARRAY SPINE COIL
- K961637 — PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
- K960973 — MOVABLE ADD-ON COUCH FOR OUTLOOK
- K960920 — CLINIX MP
- K961168 — VIEWPOINT
- K960294 — PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
- K955484 — XENON OPTION TO PRISM 3000
- K955268 — PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K954646 — EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
- K954196 — UNIVERSIX 120
- K945827 — OUTLOOK
- K953336 — VRS 3 WALL STAND
- K953402 — UNIVERSIX 190
- K952530 — HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
- K943623 — PQ5000 CT SYSTEM
- K945828 — ECHO PLANAR IMAGING I
- K945743 — PREFERENCE MAMMOGRAPHY SYSTEM
- K945397 — ANGIO II
- K944816 — SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
- K945580 — DSP OPTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.