FDAMay 6, 2022device

VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF A...

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

The hazard

Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

What to do

FDA enforcement status: Ongoing

Brands named

getinge usa salesgetingegetinge usa

UPCs

37007124008733700712400866370071240090337007124016033700712401566370071240176437007124017263700712401597370071240155937007124017573700712401719

Recall history

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

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