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
    76600
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-18
  • 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
    Some digital accelerators have increased electron applicator auto-tracking settings in the field to values greater than the factory-set defaults. incresing auto-tracking values from factory set defaults can result in the system becoming non-compliant with iec standards in particular with the safety standard iec 60601-2-1.

Device

ELEKTA INFINITY
  • Model / Serial
    Model Catalog: XRT 1501 (Lot serial: all serial numbers); Model Catalog: XRT 1511 (Lot serial: all serial numbers); Model Catalog: MRT 2161 (Lot serial: all serial numbers); Model Catalog: MRT 3041 (Lot serial: all serial numbers); Model Catalog: XRT 0101 (Lot serial: all serial numbers); Model Catalog: MRT 6011 (Lot serial: all serial numbers); Model Catalog: MRT 6001 (Lot serial: all serial numbers); Model Catalog: MRT 10601 (Lot serial: all serial numbers); Model Catalog: XRT 0401 (Lot serial: all serial numbers); Model Catalog: XRT 0411 (Lot serial: all serial numbers)
  • Product Description
    ELEKTA INFINITY
  • Manufacturer
    ELEKTA INC.

Manufacturer

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