Events

Recall of MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System Affected Systems: Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi.

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-2015-RN-00675-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00675-1
  • 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 gradient cable in the acgd cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on x gradient amplifier. this could cause images to be flipped left-right with incorrect orientation annotation. incorrect information taken from study images could result in inappropriate treatment decisions, but should be obvious to the operator. injury or impairment might result if undetected. there have been no injuries reported as a result of this issue.
  • Action
    GE is advising hospitals that a geometry check will identify if the issue is occurring. A GE Healthcare representative will contact the customer to arrange an appointment to correct the affected device. This action has been closed-out on 15/08/2016.

Device

MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System Affected Systems: Signa Infinity MR ...
  • Model / Serial
    MR ACGD Cabinet FRU X Gradient Cable used with GE MRI SystemAffected Systems: Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi.ARTG Number: 223115
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd