Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are Recalled by Maquet Cardiovascular Us Sales, Llc Due to Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular Us Sales, Llc directly.
Affected Products
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.
Quantity: 646 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report