Events

Recall of SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR Systems Elevated temperature of the SENSE Body Coil 1.5T cables

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-00584-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00584-1
  • 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 instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the qbc.
  • Action
    Philips is reiterating the warnings in the IFU regarding positioning the cables and leads. A sleeve is being developed that will be applied to the cable on the SENSE Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating.

Device

SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR Systems Elevated temperatu...
  • Model / Serial
    SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR SystemsElevated temperature of the SENSE Body Coil 1.5T cablesARTG #: 98887
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA