Recall Z-1872-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
| Date | May 20, 2024 (initiated Apr 15, 2024) |
| Status | Open, Classified |
| Reason | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity |
| Root cause | Under Investigation by firm |
| Action | Philips issued URGENT Medical Device Correction Letter on 4/15/24 to US consignees. [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 Device Correction Letter to all users of this device so that they are aware of t |
| Quantity | 155 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212441 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., Apr 27, 2022 |