Z-2239-2025 Class II Ongoing
FDA device recall Z-2239-2025 was initiated by Philips Medical Systems (Cleveland) Inc on July 17, 2025 and is designated Class II. Reason for recall: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) , The recall status is ongoing. Affected quantity: 149 Serial Numbers.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- July 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 Serial Numbers
Product Description
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Reason for Recall
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Distribution Pattern
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Code Information
Software Version Number: 18.0.5/UDI: (01)00884838103566