The Oncology Essentials Package of the Spectral CT imaging system — Class II medical device recall Z-1756-2024
Ongoing recall by Philips North America Llc, reported 2024-05-08, distributed nationwide. Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can poten
| Recall number | Z-1756-2024 |
|---|---|
| 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 | 2024-03-29 |
| Classified | 2024-05-02 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CN, NZ, PT |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 00884838101111 |
| Serial numbers | 10069, 10084, 10137, 10139, 10163, 10169, 10181, 10196, 10199, 10202, 10206, 10210 |
| Model numbers | 728333 |
Product
The Oncology Essentials Package of the Spectral CT imaging system.
Reason for recall
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect 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-1756-2024. 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.