FDA Device recall Z-0306-2024
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
- FDA Device
- Class II
- ongoing
- Published 2023-11-22
On 2023-11-22 the FDA classified a Class II recall of Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0306-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-09 |
| Published | 2023-11-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason
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.
Identifiers
| code_info | UDI-DI: 00884838103627; Lot Code: 1005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0306-2024%22
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