FDA Device recall Z-0319-2024
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 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0319-2024 |
| 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
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).
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-0319-2024%22
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