FDAJune 22, 2023device

INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE

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

The hazard

The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.

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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INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE — Recall Details · AllClear