BEUDAMED
    FDA Recall Terminated

    TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.

    Recall: Z-0993-2015 · Initiated August 21, 2014

    Recall

    Recall Number
    Z-0993-2015
    Event Number
    69560
    Firm
    Maquet Medical Systems USA
    FEI Number
    3008355164
    Product Code
    OUG
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    August 21, 2014
    Posted
    January 16, 2015
    Terminated
    November 17, 2015
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.

    Reason

    The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system.

    Action

    Maquet sent an Urgent Medical Device Field Correction Letter dated August 21, 2014, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following measures until the issue is corrected: The TEGRIS equipped with a software module version up to 2.1.X.X should not be used in conjunction wiht a MAGNUS operating table system. All other MAQUET operating tables are not affected. A MAQUET service representative would contact them and arrange to have their TEGRIS software module updated. Customers with questions were instructed to contact MAQUET Technical Support at 1-888-627-8383 (press option 3, followed by option 1, then option 1 again. For questions regarding this recall call 973-709-7000.

    Distribution

    US Nationwide Distribution including NE, NY and PA.

    Quantity

    6 units