Pinnacle3 Software Version 9 — Class II medical device recall Z-2200-2015
Terminated recall by Philips Electronics North America Corporation, reported 2015-07-29, distributed in DC, PR. Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is bei
| Recall number | Z-2200-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2014-07-31 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2019-05-08 |
| Distributed | DC, PR |
| Countries outside the US | AT, AU, BD, BE, BG, BR, CA, CH, CN, DE, DK, EG, ES, FR, GB, HK, HU, ID, IE, IN, IT, JO, JP, KR, LU, MX, MY, NL, NZ, OM, PH, PL, RO, RU, SG, TH, TR, TW, VN, ZA |
| Quantity | 1,642 |
| UPC / GTIN / UDI-DI | 00459800097831, 00459800220161, 00459800233291, 00459800233321, 00459800250151, 00459800250571, 00459800455341 |
| Model numbers | 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451 |
Product
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
Reason for recall
Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.
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-2200-2015. 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.