FDA Device recall Z-1324-2025
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334 by Philips Medical Systems Nederland B V, citing multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1324-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-28 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | MN |
Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Reason
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Identifiers
| code_info | Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 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-1324-2025%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.