FDA Device recall Z-2260-2023
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 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-2260-2023 |
| 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 Power (China)-Computed Tomography X-Ray System Model: 728148
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)00884838103467 (21) Serial Numbers: 530456 530338 530360 530489 530370 530363 530389 530369 530481 530350 5…UDI-DI: (01)00884838103467 (21) Serial Numbers: 530456 530338 530360 530489 530370 530363 530389 530369 530481 530350 530464 530500 530436 530301 530501 530372 530466 530368 530476 530358 530294 530421 530435 530480 530458 530342 530432 530419 530460 530502 530349 530475 530482 530431 530335 530378 530494 530492 530470 530345 530461 530374 530384 530388 530357 530404 530329 530373 530409 530462 530420 530452 530307 |
|---|
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-2260-2023%22
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