[pending] CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Pending LLM rewrite. Source: FDA_DEVICE Z-0882-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- CT 5300; Software Version Number: 4.5, 5.0, 5.1;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1) Model Number: 728285
- UDI-DI: 00884838113237
- Serial Numbers: 35071
- 800007
- 800002
- 800001
- 800004
- 800003
Distribution
Distributed nationwide across the United States.
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