The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible

FDA device recall Z-1990-2015 · posted 2015-07-07 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

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.

Action taken

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 where the arms are grinding. The correction will be performed by an authorized Maquet Service Technician. The customer will be contacted by a representative of the Maquet Service team to schedule an on-site inspection and possible service of the PowerLED / X-TEN / VOLISTA Surgical Light Systems. If the customer has any questions or require additional information, they can contact their local Maquet representative, or Maquet Customer Service at 1-888-627-8383 (option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Root cause

Device Design

Status

Terminated

Product code

FSY

Quantity affected

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, Colom

Date initiated

2015-05-29

Date posted

2015-07-07

Date terminated

2017-04-07

Location

Wayne, NJ

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