Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

FDA device recall Z-0881-2026 · posted 2025-12-03 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

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.

Action taken

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 receipt. Completing this form confirms receipt of the URGENT Medical Device Correction letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the tube heat exchanger screws and correct the loosen screw if necessary (reference FCO72800842). Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: For North America, contact the Customer Care Solutions Center {1-800-722-9377, 8AM - 8PM EST, Monday-Friday).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAK

Quantity affected

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, Bulga

Date initiated

2025-10-29

Date posted

2025-12-03

Location

Cambridge, MA

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