Recall Z-2239-2025— Philips Medical Systems (Cleveland) Inc
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17. It names one FDA 510(k) clearance: K170086. Product: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software. Reason: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,.
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-17
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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) ,
Data sourced from openFDA. This site is unofficial and independent of the FDA.