Events

Recall of INTEGRITY R1.2 - MK 3I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA INC..

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
    20068
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-03
  • 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
    Elekta have identified that it is possible to get positional error with the precise treatment table following automatic table movement. this can occur if there is an undetected failure of the positional sensors.

Device

INTEGRITY R1.2 - MK 3I
  • Model / Serial
    Model Catalog: MRT 1504976 (Lot serial: INTEGRITY R1.2); Model Catalog: MRT 23551 (Lot serial: INTEGRITY R3.2); Model Catalog: MRT 1504984 (Lot serial: INTEGRITY R1.2)
  • Product Description
    INTEGRITY R1.2 - MK 3I;INTEGRITY R3.2;INTEGRITY R1.2 - MK 4
  • Manufacturer
    ELEKTA INC.

Manufacturer

ELEKTA INC.
  • Manufacturer Address
    ATLANTA
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC