Events

Recall of MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia 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-01225-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01225-1
  • 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
    The accessory adaptor (600525a0) is designed for the mounting of maquet accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment. the accessory adapter is used with the magnus table back plates to attach the horseshoe head rest or the skull clamp. maquet has been notified of a case where a head rest was levered out of the dovetail profile of the accessory adaptor. it was identified that the raw material of the accessory adaptor did not meet maquet specifications. while the accessory adapter does carry the specified weight of 11kg at a distance of 300mm, the tensile and flexural strength of the material was less than specification.There is a very rare possibility should the attached accessory release from the adapter without warning during a surgical procedure that the patient may sustain a cervical spine injury. to date no incident has been reported in which a person was injured.
  • Action
    MAQUET will be contacting customers to provide a new replacement Accessory Adaptor (600525A0). Until the replacement has been provided, MAQUET is advising users that Accessory Adaptor (600525A0) should not be used.

Device

MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards
  • Model / Serial
    MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwardsARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA