Recall Z-2239-2025 ยท MUJ System, Planning, Radiation Therapy Treatment
Philips Medical Systems (Cleveland) Inc
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
| Date | Aug 1, 2025 (initiated Jul 17, 2025) |
| Status | Open, Classified |
| Reason | Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) , |
| Root cause | Software change control |
| Action | On July 17, 2025, Philips issued a "Urgent Medical Device Correction" Notification to affected consignees. Philips asked consignees to take the following actions: 1. You may continue to use your system(s) in accordance with the intended use and by following the recommendations below. 2. To prevent the issue from occurring, when using SPR generation, always verify data sets are from same acquisition and matching reconstruction parameters. 3. Ensure that relevant clinical staff, including physicians, physicists, and dosimetrists, are informed about the potential for incorrect dataset calcula |
| Quantity | 149 Serial Numbers |
| Distribution | Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170086 | Pinnacle Radiation Therapy Planning System Philips Medical Systems (Cleveland), Inc., Feb 9, 2017 |