CT 5300; Software Version Number: 4.5, 5.0, 5.1;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 29, 2025 |
| Reported | December 10, 2025 |
| Recalling firm | Philips North America Llc |
| Country / region | United States MA |
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.
Affected products
- CT 5300; Software Version Number: 4.5, 5.0, 5.1;
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