Philips Medical Systems (Cleveland) Inc: Device Recall

Recall #Z-2239-2025 · 07/17/2025

Class II: Risk

Recall Details

Recall Number: Z-2239-2025
Classification: Class II
Product Type: Device
Recalling Firm: Philips Medical Systems (Cleveland) Inc
Status: Ongoing
Date Initiated: 07/17/2025
Location: Gainesville, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 149 Serial Numbers

Reason for Recall

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

Product Description

Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

Distribution Pattern

Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.

Other Recalls by Philips Medical Systems (Cleveland) Inc

Class II: Risk 08/05/2025

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.

View all recalls by Philips Medical Systems (Cleveland) Inc →

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.