Events

Recall of Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems

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-00632-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00632-1
  • 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
    Ge healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity. if a device is improperly re-installed, the collimator may not be properly seated and may loosen and fall. such an event may occur immediately following re-installation during a servicemaintenance activity, but may also occur a few months after a service activity and continued use. a fall of a collimator while the system is in use could result in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
  • Action
    GE is advising customers that if they observe any abnormal collimator movement, immediately stop using the system and contact their local GE Healthcare Service Representative. During planned maintenance, customers are also advised not to perform the demounting and re-mounting of collimator for Proteus XR/a and Revolution XR/d X-ray imaging systems as stated in the manuals. A GE Healthcare service representative will contact customers to verify that all affected systems are properly installed and to implement correction if necessary.

Device

Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems
  • Model / Serial
    Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systemsProteus XR/a X-ray imaging systems installed with collimator part numbers 2261763 and 2261765 ARTG 98099 All Revolution XR/d X-ray imaging systemsARTG 114083
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd