FDAMay 29, 2015device
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascular us salesmaquetmaquet cardiovascular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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