CT 5300 (Philips) – Scanner Component Detachment (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Brand
Philips North America Llc
Lot Codes / Batch Numbers
1) Model Number: 728285, UDI-DI: 00884838113237, Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003
Products Sold
1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;
Philips North America Llc is recalling CT 5300; Software Version Number: 4.5, 5.0, 5.1; due to If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make conta. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026