Philips Medical Systems (cleveland), Inc.
FDA adverse event reports naming Philips Medical Systems (cleveland), Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC..
- Total reports
- 1,549
- Deaths
- 6
- Injuries
- 43
- Malfunctions
- 1,099
Reports per year
Source: FDA adverse event reports by year received, 2010–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, X-Ray, Tomography, ComputedJAK1,251
- System, Tomography, Computed, EmissionKPS255
- System, Planning, Radiation Therapy TreatmentMUJ13
- Camera, Scintillation (Gamma)IYX11
- System, Image Processing, RadiologicalLLZ11
- System, Nuclear Magnetic Resonance ImagingLNH4
- Table, Radiographic, TiltingIXR1
- System, X-Ray, TomographicIZF1
- System, X-Ray, StationaryKPR1
- Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB1
Recent recalls
- 2025-09-16Open, ClassifiedSoftware design
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.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
- 2025-08-01Open, ClassifiedSoftware change control
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
- 2022-09-15Open, ClassifiedDevice Design
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
- 2019-11-01TerminatedNonconforming Material/Component
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.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- 2019-11-01TerminatedNonconforming Material/Component
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.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- 2019-11-01TerminatedNonconforming Material/Component
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.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- 2019-11-01TerminatedNonconforming Material/Component
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.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- 2019-11-01TerminatedNonconforming Material/Component
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.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- 2019-08-06TerminatedOther
Ingenuity CT, Model # 728326, computed tomography x-ray system
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
- 2019-08-06TerminatedOther
Ingenuity Core128 Model # 728323, computed tomography x-ray system
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
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