BEUDAMED
    FDA Recall Terminated

    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

    Recall: Z-2097-2015 · Initiated June 10, 2015

    Recall

    Recall Number
    Z-2097-2015
    Event Number
    71446
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 10, 2015
    Posted
    July 17, 2015
    Terminated
    April 18, 2016
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

    Reason

    There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a collision.

    Action

    Maquet sent a field correction letter dated June 8, 2015, via Fed Ex. Customers are advised of the issue with the device and provided instructions. Questions or additional information can be obtained from the local Maquet representative or Maquet Technical Support at 1-888-627-8383 (option 3 followed by option 1) Monday through Friday between the hours of 8:00 am and 6:00 pm EST.

    Distribution

    Worldwide Distribution - US Nationwide Distribution and to the countries of : France, Australia, Belgium, Brazil, Switzerland, Chile, China, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Japan, Kuwait, Kazakhstan, Mexico, Netherlands, Norway, Russia, Sweden, Turkey, Taiwan and South Africa.

    Quantity

    12 units