BEUDAMED
    FDA Recall Terminated

    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.

    Recall: Z-1405-2017 · Initiated January 30, 2017

    Recall

    Recall Number
    Z-1405-2017
    Event Number
    76351
    Firm
    ErgoSafe Products, LLC (DBA) Prism Medical
    FEI Number
    3007802293
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 30, 2017
    Posted
    February 28, 2017
    Terminated
    December 4, 2017
    Address
    10888 Metro Ct, Maryland Heights, MO, 63043-2413

    Description

    A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.

    Reason

    During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.

    Action

    The recalling firm called each customer on Jan 30, 2017 to review the recall and schedule a time for the firm to come to their facility to personally swap the recalled product for a new device. The FSNs were sent on Jan 31, 2017.

    Distribution

    Product was distributed to MT and NV; one VA consignee.

    Quantity

    21