BEUDAMED
    FDA Recall Terminated

    Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V

    Recall: Z-1894-2017 · Initiated March 8, 2017

    Recall

    Recall Number
    Z-1894-2017
    Event Number
    77075
    Firm
    Sonesta Medical Ab Adolfsbergsvagen 31 Bromma Sweden
    FEI Number
    3010496070
    Product Code
    MMZ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 8, 2017
    Terminated
    August 20, 2019

    Description

    Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V

    Reason

    The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

    Action

    Sonesta notified customers (distributors) on March 8, 2017, of the faulty labeling. Corrected labeling was sent to customers, they were requested to apply the new labels and confirm that the correction was implemented. For further information regarding this recall, please call (512) 327-9997.

    Distribution

    Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy

    Quantity

    28 devices