Recall Z-2258-2023 ยท JAK System, X-Ray, Tomography, Computed
Philips North America
Incisive CT-Computed Tomography X-Ray System Model: 728143
| Date | Jul 28, 2023 (initiated Apr 25, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Phiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23 International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical D |
| Quantity | 36 US; 610 OUS |
| Distribution | Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Mace |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180015 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., Mar 20, 2018 |