Events

Recall of Mizuho OSI 5855 Orthopedic Table Top Manufactured January 1996 through December 2007

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare Pty Ltd.

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
    RC-2013-RN-00069-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00069-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    This action has been initiated to eliminate the risk of de-lamination of the epoxy bond between the 5855-01 orthopedic table spar's aluminium insert and the carbon fibre spar itself. if the epoxy bond fails the aluminium plug may migrate out of the carbon fibre tube.
  • Action
    Customers are being advised to inspect the table top for any evidence of a shift of the aluminium plug from the carbon spar and immediately contact LifeHealthcare if apparent. Hospitals will be contacted to schedule an appointment to replace the table spar.

Device

Mizuho OSI 5855 Orthopedic Table Top Manufactured January 1996 through December 2007
  • Model / Serial
    Mizuho OSI 5855 Orthopedic Table TopManufactured January 1996 through December 2007ARTG 183118
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd