Recall Z-1990-2015 ยท FSY Light, Surgical, Ceiling Mounted
Maquet Cardiovascular Us Sales, Llc
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.
| Date | Jul 7, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Maquet Medical Systems sent an Urgent Medical Device Field Correction letter dated May 29, 2015, to all affected customers via Fedex. The letter identified the product the problem and the action needed to be taken by the customer. The customer was informed that the correction will include inspection of PowerLED / X-TEN / VOLISTA Surgical Light Systems mounted above the surgical table and replacement of the suspension arms if found to be defective. As a remedial measure, pending replacement of the defective suspensions, Maquet personnel will install a protective plastic strip at each junction |
| Quantity | 646 units |
| Distribution | 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, Ec |
| FDA record | Open on fda.gov |