Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0881-2026 — Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

U.S. FDA — Device Enforcement · United States · 2025-10-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0881-2026
Date of alert
2025-10-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838085015
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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