Spectral CT on Rails — Class II medical device recall Z-0319-2024
Ongoing recall by Philips North America, reported 2023-11-22, distributed nationwide. This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the
| Recall number | Z-0319-2024 |
|---|---|
| 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 | 2023-11-16 |
| 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
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
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-0319-2024. 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.