FDA Device recall Z-2259-2023
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 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-2259-2023 |
| 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 for Brazil SKD-Computed Tomography X-Ray System Model: 728146
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)00884838104481(21) Serial Numbers: 540009 540008 540015 540012 540016 540017 540003 540004 540005 540006 54…UDI-DI: (01)00884838104481(21) Serial Numbers: 540009 540008 540015 540012 540016 540017 540003 540004 540005 540006 540007 540001 540011 540000 540014 540013 540018 540010 540002 |
|---|
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-2259-2023%22
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