Events

Recall of Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C2-9-D, IC-5-9-D and M5Sc-DARTG Number: 146317

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-00411-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00411-1
  • 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 recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (c1-5-d, c2-9-d, ic5-9-d and m5sc-d) are incorrect. this may result in a situation where probes can overheat. if a certain specific hardware failure occurs on the vivid e9 transmitter board (gtx192) this may, in combination with the incorrect power surveillance settings mentioned above, result in an overheating of the probe surface on the listed probes. no overheating of the probes listed above has been reported.
  • Action
    GE is requesting their customers to cease using the IC5-9-D probe until the systems have been corrected. If any other prodes are observed to be over heating customers should discontinue using the Vivid E9 system and contact GE immediately.

Device

Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C...
  • Model / Serial
    Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C2-9-D, IC-5-9-D and M5Sc-DARTG Number: 146317
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd