Events

Recall of ELEKTA INFINITY

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
    15891
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-23
  • 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
    A malfunction of modular reverse diodes (d1a) a component in the equipment room of the elekta linear accelerator which have ruptured. failures have occured after beam termination.

Device

ELEKTA INFINITY
  • Model / Serial
    Model Catalog: XRT 1511 (Lot serial: 151941); Model Catalog: XRT 1501 (Lot serial: 151941); Model Catalog: XRT 1511 (Lot serial: 151940); Model Catalog: XRT 1501 (Lot serial: 152094); Model Catalog: XRT 1511 (Lot serial: 151939); Model Catalog: XRT 1501 (Lot serial: 151939); Model Catalog: XRT 1511 (Lot serial: 152094); Model Catalog: XRT 1501 (Lot serial: 151940); Model Catalog: XRT 0411 (Lot serial: PLEASE CONTACT MANUFACTURER.); Model Catalog: XRT 0401 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: XRT 0411 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: XRT 0401 (Lot serial: PLEASE CONTACT MANUFACTURER.); Model Catalog: MRT 6001 (Lot serial: 105706); Model Catalog: MRT 6011 (Lot serial: 105785); Model Catalog: MRT 6001 (Lot serial: 151311); Model Catalog: MRT 6011 (Lot serial: 105627); Model Catalog: MRT 6001 (Lot serial: 105627); Model Catalog: MRT 6011 (Lot serial: 151578); Model Catalog: MRT 6001 (Lot serial: 151578); Model Catalog: MRT 6011 (Lot serial: 105706); Model Catalog: MRT 6001 (Lot seri
  • Product Description
    ELEKTA INFINITY
  • Manufacturer
    ELEKTA INC.

Manufacturer

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