BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1990-2015 · Initiated May 29, 2015

    Recall

    Recall Number
    Z-1990-2015
    Event Number
    71351
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 29, 2015
    Posted
    July 7, 2015
    Terminated
    April 7, 2017
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    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.

    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.

    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 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.

    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, Ecuador, Egypt, Spain, Finland, France, Greenland, Greece, Hong Kong, United Arab Emirate, United Kingdom, Kenya, Kuwait, Sri Lanka, Luxembourg, Libya, Mongolia, Martinique, Mexico, Malaysia, Namibia, Nigeria, Netherlands, Norway, Oman, Panama, Peru, Philippines, Pakistan, Poland, Saint Pierre and Miquelon, Portugal, Reunion, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Thailand, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Uruguay, Venezuela, Serbia, Yemen, Mayotte and South Africa.

    Quantity

    646 units