Maquet Cardiovascular Us Sales, Llc recalls The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible…

Recall date

May 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1990-2015

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Austria, Australia, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Croatia, Hungary, Indonesia, Ireland, Iraq, Jordan, Japan, Czech Republic, Germany, Denmark, E…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.