BEUDAMED
    FDA Recall Terminated

    Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.

    Recall: Z-0285-2016 · Initiated September 8, 2015

    Recall

    Recall Number
    Z-0285-2016
    Event Number
    71680
    Firm
    ErgoSafe Products, LLC (DBA) Prism Medical
    FEI Number
    3007802293
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 8, 2015
    Posted
    November 17, 2015
    Terminated
    May 4, 2017
    Address
    10888 Metro Ct, Maryland Heights, MO, 63043-2413

    Description

    Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.

    Reason

    Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use

    Action

    The firm, Prism Medical, sent a "Field Safety Notice (FSN 0008)" letter dated 9/8/2015 to all consignees by email via their sales portal. The letter describes the product, problem and actions to be taken. The consignees were instructed to call Prism Medical directly at 1-314-219-8655 and indicate that you are participating in the 300 series lift recall; provide your existing 300 series lift model number and serial number; follow the instructions provided; complete and return the Acknowledgement Form via scanned & signed to [email protected] or fax to: 314-692-7858, Attention: 300 series recall. For further information please contact: Prism Medical Quality department at: 1-314-219-8655 or North American Director for Quality & Regulatory Affairs at 1-314-219-8614.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain.

    Quantity

    1,721 lifts