Events

Recall of MSK 1.5T Extreme and Optima MR430s (MRI 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-2016-RN-00652-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00652-1
  • 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
    A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. there have been no injuries reported as a result of this issue. at this site, a magnet heater probe connection became disconnected. this resulted in ice build-up within the magnet blocking the cryogen vent. since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.
  • Action
    GE Healthcare is advising users to notify GE Service Engineer if the Magnet Monitoring Unit (MMU) detects any abnormal or out of specification reading. If the Magnet Monitoring Unit (MMU) detects an error it will display a pop-up window on the system monitor which will be seen by the operator. MMU reported errors will be in the form of a CAS7XX error (XX being the specific error) with a brief description. If no Magnet Monitoring Unit errors are reported, there are no action is required. Users can continue normal use of the affected products. GE will be correcting all affected units. This action has been closed out on 13 Jun 2017.

Device

MSK 1.5T Extreme and Optima MR430s (MRI Systems)

Manufacturer

GE Healthcare Australia Pty Ltd