Philips Medical Systems (Cleveland) Inc

2 FDA enforcement actions

2 Total Recalls

0 Class I

2 Class II

0 Class III

Firm Details

Product Types: device
States: FL

All Recalls

Class II: Risk 08/05/2025 device

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.
Class II: Risk 07/17/2025 device

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.