BEUDAMED
    FDA Recall Terminated

    Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants

    Recall: Z-2291-2016 · Initiated June 24, 2016

    Recall

    Recall Number
    Z-2291-2016
    Event Number
    74529
    Firm
    Moller Vital Hadelandsvegen 2
    FEI Number
    3004137175
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 24, 2016
    Posted
    July 26, 2016
    Terminated
    June 23, 2017
    Address
    P.o. Box 408, Gjovik Norway

    Description

    Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants

    Reason

    Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing.

    Action

    Moller Vital sent a Field Safety Corrective Action on June 22, 2016. Field correction instructions were provided to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to read the instruction, and return the recipient confirmation, report all serial numbers distributed in their region/country to Etac Supply Gjovik, order the upgrade kit from Etac Supply Gjovik, Customers were also instructed to follow up with the customers and users and confirm that all hoists in their market are upgraded. Customers with questions were instructed to contact Etac Supply Gjovik.at [email protected].

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to SZ, TR, BE, CH, DE, DK, ES, FI, FR, GB, IS LV, NL, NO, SE, SI, AU, CN, IL, JP, NZ, IN, QA, PE, AE

    Quantity

    516 units (374 US)