Recall database

Philips Medical Systems (Cleveland) Inc recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2570-2025

Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.…

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.

Radiation Therapy Treatment Planning System
Software design

Philips Medical System…FLSep 24, 2025

Class IIOngoingZ-2239-2025

Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC

Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

Radiation Therapy Treatment Planning System
Software change control

Philips Medical System…FLAug 13, 2025