Recall Z-0881-2026— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2025-10-29. It names 3 FDA 510(k) clearances: K232491, K212441, K180015. Product: Incisive CT; Software Version Number: 4.5, 5.0, 5.1;. Reason: 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..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-29
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.