Recall Z-0881-2026 · JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
| Date | Dec 3, 2025 (initiated Oct 29, 2025) |
| Status | Open, Classified |
| Reason | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger. |
| Root cause | Under Investigation by firm |
| Action | On October 23, 2025 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Please continue to use your system in accordance with its intended use and do not stay in the scan room when scanning. 2. Circulate this URGENT Medical Device Correction letter to all users of this device so that they are aware of the issue. 3. Place this URGENT Medical Device Correction with your system documentation and ensure the letter is in a place likely to be seen/viewed. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from |
| Quantity | 2341 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Rep |
| FDA record | Open on fda.gov |