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

Recall Z-2385-2016 — Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.

U.S. FDA — Device Enforcement · United States · 2016-04-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2385-2016
Date of alert
2016-04-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Reported risk: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
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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