FDA Device recall Z-2261-2023
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 by Philips North America, citing metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2261-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-25 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Reason
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Identifiers
| code_info | UDI-DI: (01)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430 |
|---|
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-2261-2023%22
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