Events

Recall of INTEGRITY 1.1 INSTALL + RECOVERY MK 4

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
    18057
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-10
  • 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
    During beam delivery the tolerance values are used to do a check for unwanted movements. these values are known as static tolerances which are related to all the digital accelerator geometric movement axes except table column. the problem is that the static tolerances from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. a fault occurs if the loaded database is incorrect.

Device

INTEGRITY 1.1 INSTALL + RECOVERY MK 4
  • Model / Serial
    Model Catalog: 1016710 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1016708 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    INTEGRITY 1.1 INSTALL + RECOVERY MK 4
  • Manufacturer
    ELEKTA INC.

Manufacturer

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