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

Recall Z-1289-2022 — System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

U.S. FDA — Device Enforcement · United States · 2022-05-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1289-2022
Date of alert
2022-05-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Canon Medical System, USA, INC.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04987670100192
Reported risk: CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
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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