FDA Device recall Z-1054-2024
Spectral CT on Rails: Software Version 5.1.0.X, model 728334
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Spectral CT on Rails: Software Version 5.1.0.X, model 728334 by Philips Medical Systems, citing A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1054-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-13 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Reason
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Identifiers
| code_info | UDI-DI: 00884838103627, serial number: 1005. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1054-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.