DS/US Proton Feature with Pinnacle3 Software Version 10 — Class II medical device recall Z-0745-2016
Terminated recall by Philips Medical Systems, reported 2016-02-10, distributed nationwide. In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating
| Recall number | Z-0745-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Andover, MA, United States |
| Recall initiated | 2016-01-08 |
| Classified | 2016-02-02 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Model numbers | 459800200621 |
Product
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Reason for recall
In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0745-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.