BEUDAMED
    FDA Recall Terminated

    Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic

    Recall: Z-1160-2012 · Initiated October 28, 2011

    Recall

    Recall Number
    Z-1160-2012
    Event Number
    60285
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    FEM
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    October 28, 2011
    Posted
    March 5, 2012
    Terminated
    January 14, 2014
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic

    Reason

    Replacement wheels may break off from the base of the cart

    Action

    OLYMPUS sent an Urgent - Device Correction letter dated October 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. OLYMPUS required customers indicate on the attached questionnaire the contact information for their facility so that they can schedule a convenient time for an Olympus Field Service Representative to visit. Service personnel would inspect, and replace, as necessary any user installed casters on the WM-P1 cart. For questions regarding this recall call (483) 896-5688.

    Distribution

    Nationwide Distribution including AL, CA, NY and WV.

    Quantity

    5