Events

Recall of OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2014-RN-00389-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00389-1
  • 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 screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to fall forward.
  • Action
    A GE HealthCare Field Engineer will replace the screwS to ensure that the system is operating safely and meets all specifications. Until the correction is complete, end users are advise to use caution when positioning or extending the arm. In addition, refrain from positioning staff or patients directly underneath or in front of a work station monitor.

Device

OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9...
  • Model / Serial
    OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected. ARTG Number: 132698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd