Spectral CT on Rails — Class II medical device recall Z-0306-2024
Ongoing recall by Philips North America, reported 2023-11-22, distributed nationwide. When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may exp
| Recall number | Z-0306-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-10-09 |
| Classified | 2023-11-15 |
| Reported by FDA | 2023-11-22 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838103627 |
| Lot numbers | 1005 |
| Model numbers | 728334 |
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason for recall
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
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-0306-2024. 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.