BEUDAMED
    FDA Recall Terminated

    Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).

    Recall: Z-0294-2012 · Initiated October 7, 2011

    Recall

    Recall Number
    Z-0294-2012
    Event Number
    60031
    Firm
    Pelstar, Llc
    FEI Number
    1420128
    Product Code
    FRI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 7, 2011
    Posted
    November 28, 2011
    Terminated
    November 30, 2017
    Address
    11800 S Austin Ave, Unit B, Alsip, IL, 60803-3559

    Description

    Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).

    Reason

    There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke, burn or burst.

    Action

    Pelstar LLC. sent a Urgent Device Recall letter dated October 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed them of the potential of an electrical short caused when installing or replacing the batteries which may result in minor injuries to the person installing the batteries. The customers were requested to immediately examine their inventory and quarantine all product subject to the recall. In addition, if they distributed this product to end users, they were requested to identify all customers and notify them of this product recall at once in writing, using the enclosed recall notification letter. The customers were also requested to complete and return the enclosed mandatory response form as soon as possible. Any questions were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.

    Distribution

    Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.

    Quantity

    2,498 units