FDAApril 17, 2024device

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

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

The hazard

X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

What to do

FDA enforcement status: Ongoing

Brands named

nrt x ray a snrt

UPCs

0571346400052705713464000121

Recall history

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

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