Philips Medical Systems (Cleveland) Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)008Class IIAug 5, 2025Due to a software issue, there is a potential image error of	Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction	Class IIDevices	Aug 5, 2025
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System SoftwareClass IIJul 17, 2025Due to software issue, Radiation Therapy Planning system ma	Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when perf	Class IIDevices	Jul 17, 2025
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.Class IIAug 30, 2022When computing a radiation dose in the system, the exported	When computing a radiation dose in the system, the exported dose information is incorrect when there is more t	Class IIDevices	Aug 30, 2022