FDA Device recall Z-2258-2023
Incisive CT-Computed Tomography X-Ray System Model: 728143
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Incisive CT-Computed Tomography X-Ray System Model: 728143 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-2258-2023 |
| 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-Computed Tomography X-Ray System Model: 728143
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) 00884838085015 (21) + Serial number Serial Numbers: 33001 33002 33003 33005 33006 33007 33008 33009 33010…UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers: 33001 33002 33003 33005 33006 33007 33008 33009 33010 33011 33012 33013 33015 33016 33017 33019 33020 33024 33025 33031 33033 33034 33035 33037 33038 33039 33041 33042 33045 33046 33047 33049 500252 500255 500282 500301 OUS: System Serial Number 530117 33018 33021 33022 33023 33026 33027 33029 33030 33032 33036 33040 33043 33044 500241 500244 500245 500246 500247 500248 500253 500254 500256 500257 500258 500259 500260 500261 500262 500263 500264 500265 500266 500267 500268 500269 500270 500271 500272 500273 500274 500275 500276 500277 500278 500279 500283 500284 500285 500286 500287 500288 500293 500296 500298 500299 500300 500302 500303 500304 500305 500306 500307 500308 500309 500310 500311 500312 500313 500314 500315 500316 500317 500318 500319 500320 500321 500322 500323 500324 500325 500326 500327 500328 500329 500330 500331 500332 500333 500334 500335 500336 500337 500338 500339 500340 500341 500342 500343 500344 |
|---|
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-2258-2023%22
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