FDAApril 10, 2023device

Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units

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

The hazard

Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.

What to do

FDA enforcement status: Ongoing

Brands named

shimadzu corporation medical systems divisionshimadzushimadzu corporation

UPCs

0454021703143604540217062782

Recall history

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

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