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FDAOctober 29, 2025device

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838113237

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CT 5300; Software Version Number: 4.5, 5.0, 5.1; — Recall Details · AllClear