Food, drugs, devices › Philips Medical Systems (Cleveland) Inc
Device recall: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
FDA enforcement event 97309 is a device recall by Philips Medical Systems (Cleveland) Inc of Gainesville, FL, initiated 17 Jul 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips Medical Systems (Cleveland) Inc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Medical Systems (Cleveland) Inc, Gainesville, FL.
Reason for recall
"Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,"
Distribution
"Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2239-2025 | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software | 149 Serial Numbers | Class II | Ongoing | 13 Aug 2025 |
Context
Other enforcement events for Philips Medical Systems (Cleveland) Inc
All 129 events for Philips Medical Systems (Cleveland) Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.