FDAMay 3, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

canon medical systemcanoncanon medical

UPCs

04987670100192

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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