Class II — Philips Medical Systems
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 |
| Quantity | 3 |
| Distribution | US: Nationwide Distribution in the states of FL, OH, and MO. |
| Initiated | 2016-01-08 |
| Classified | 2016-02-02 |
| Terminated | 2016-10-05 |
| Recall number | Z-0745-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems (Z-0745-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73023/
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