FDAFebruary 7, 2018device

VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be insta...

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

The hazard

The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

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

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