FDA Device recall Z-1825-2026
Philips Spectral CT on Rails
- FDA Device
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of Philips Spectral CT on Rails by Philips Medical Systems, citing philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1825-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-07 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips Spectral CT on Rails. Model Number: 728334.
Reason
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
Identifiers
| code_info | Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software…Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1825-2026%22
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