Events

Recall of Mizuho General Purpose Operating Table

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hipac 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-2016-RN-00394-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00394-1
  • 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
    There is a possibility that the column top may pull loose and the foot end may hit the floor, potentially resulting in the patient falling from the table top.
  • Action
    Hipac will provide unaffected loan units to customers and arrange for the repair of the affected units. This action has been closed-out o 15/02/2017.

Device

Mizuho General Purpose Operating Table
  • Model / Serial
    Mizuho General Purpose Operating TableModel Number: 3502XSerial Numbers: MAT-2013X-0013, MAT-2013X-0014 and MAT-2013X-0015ARTG Number: 219805
  • Manufacturer
    Hipac Healthcare Pty Ltd

Manufacturer

Hipac Healthcare Pty Ltd