Brilliance CT Big Bore with software version V4 — Class II medical device recall Z-0293-2024
Ongoing recall by Philips North America Llc, reported 2023-11-22, distributed nationwide. For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the
| Recall number | Z-0293-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2023-10-09 |
| Classified | 2023-11-14 |
| Reported by FDA | 2023-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CN, DE, EE, ES, FR, IN, IT, MX, NL, PH, PL, SG, TW |
| Quantity | 11 units |
| UPC / GTIN / UDI-DI | 00884838059450 |
| Serial numbers | 75043, 760012, 76005, 76038, 76134, 76137, 76202, 7742, 7825, 7830, 7871 |
| Model numbers | 728244 |
Product
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
Reason for recall
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
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-0293-2024. 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.