BEUDAMED
    FDA Enforcement Class II 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 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1488-2013
    Event ID
    65062
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Berchtold Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    March 12, 2013
    Classification Date
    June 6, 2013
    Termination Date
    May 8, 2017
    Address
    1950 Hanahan Rd, N/A, N Charleston, SC, 29406-4878, United States

    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.

    Code Info

    The hand controls are neither serialized nor lot coded.

    Distribution

    Nationwide Distribution

    Quantity

    3763