Events

Recall of OPERON SURGICAL TABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BERCHTOLD MEDIZIN-ELEKTRONIK GMBH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15025
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Berchtold has identified a potential for unintended table section movements if fluids enter the hand control. unintended movements during a surgical procedure can cause he patient to move into positions that compromise the safety of patient such as the possibility of the patient falling off the table or causing injury by impacting other surgical surgical tools being used during the procedure.

Device

OPERON SURGICAL TABLE
  • Model / Serial
    Model Catalog: D850 (Lot serial: ALL); Model Catalog: D820 (Lot serial: ALL); Model Catalog: D750 (Lot serial: ALL); Model Catalog: D752 (Lot serial: ALL); Model Catalog: D760 (Lot serial: ALL)
  • Product Description
    HAND CONTROLS FOR OPERON SURGICAL TABLES
  • Manufacturer
    BERCHTOLD MEDIZIN-ELEKTRONIK GMBH

Manufacturer

BERCHTOLD MEDIZIN-ELEKTRONIK GMBH
  • Manufacturer Address
    TUTTLINGEN
  • Source
    HC