Events

Recall of DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    25331
  • Event Risk Class
    III
  • Event Initiated Date
    2015-08-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The predicted head sar value from the modeling when using ge healthcare 3.0t mr scanners with the whole body rf transmit coil and receive-only surface coils for head and/or neck imaging suggests that actual sar delivered to the head could potentially exceed the 3.2 w/kg sar limit defined in iec60601-2-33. this issue does not affect mr scans performed outside the head and neck areas.

Device

DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0010); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 663); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0364); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0042); Model Catalog: M3335JJ (Lot serial: 00000279069MR9); Model Catalog: M3335JJ (Lot serial: 00000HDMR10727); Model Catalog: M7000BD (Lot serial: 00000291154MR3); Model Catalog: M7000BD (Lot serial: 00000303327MR1); Model Catalog: M7000BD (Lot serial: 00000300711MR9); Model Catalog: M7000BD (Lot serial: 00000298951MR5); Model Catalog: M7000BD (Lot serial: 000000000R2726); Model Catalog: M7000BD (Lot serial: 00000296265MR2); Model Catalog: M7000BD (Lot serial: 00000299547MR0); Model Catalog: M7000BD (Lot serial: 00000291008MR1); Model Catalog: M7000BD (Lot serial: 00000296200MR9); Model Catalog: M7000BD (Lot serial: 00000300563MR4)
  • Product Description
    DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)