BEUDAMED
    FDA Recall Terminated

    Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables

    Recall: Z-1488-2013 · Initiated March 12, 2013

    Recall

    Recall Number
    Z-1488-2013
    Event Number
    65062
    Firm
    Berchtold Corp.
    FEI Number
    1220685
    Product Code
    GDC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 12, 2013
    Posted
    June 6, 2013
    Terminated
    May 8, 2017
    Address
    1950 Hanahan Rd N, Charleston, SC, 29406-4878

    Description

    Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables

    Reason

    The firm received complaints for unintended movements.

    Action

    Berchtold sent an Urgent Medical Device Recall letter in March 2013, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were recommended to clean the affected product and use the instructions to reduce the possibility of unintended movements until the firm could replace the affected product. Customers with questions were advised to contact the Berchtold Operon Pendanct Recall Coordinator at 800-243-5135, or 843-569-6100, ext 306. For questions regarding this recall call 843-569-6133.

    Distribution

    Nationwide Distribution

    Quantity

    3763