FDA Medical devices recall ·
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System… recall
- Recall number
- Z-2239-2025
- Date
- (initiated July 17, 2025)
- Company / brand
- Philips Medical Systems (Cleveland) Inc
3630 Sw 47th Ave, Gainesville, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 149 Serial Numbers
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Why was it recalled?
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Version Number: 18.0.5/UDI: (01)00884838103566
Distribution
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
States: West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2239-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.