Events

Recall of CLARITY SYSTEM - MAIN UNIT

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

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
    82810
  • Event Risk Class
    III
  • Event Initiated Date
    2011-04-11
  • 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 reconstructed image produced from a linear ultrasound probe may be spatially displaced causing a potential patient positioning error that may be outside of expected system performance specifications (+/-2mm).

Device

CLARITY SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 110R00 (Lot serial: VERSION 2.2); Model Catalog: 110C00 (Lot serial: VERSION 1.3); Model Catalog: 110R00 (Lot serial: VERSION 2.1); Model Catalog: 110C00 (Lot serial: VERSION 2.1); Model Catalog: 110R00 (Lot serial: VERSION 2.0); Model Catalog: 110C00 (Lot serial: VERSION 2.0); Model Catalog: 110R00 (Lot serial: VERSION 1.3); Model Catalog: 110C00 (Lot serial: FOR ALL BREAST WORKFLOW ONLY); Model Catalog: 110R00 (Lot serial: FOR ALL BREAST WORKFLOW ONLY); Model Catalog: 110C00 (Lot serial: VERSION 2.2)
  • Product Description
    CLARITY SYSTEM - MAIN UNIT
  • Manufacturer
    ELEKTA LTD.

Manufacturer

ELEKTA LTD.
  • Manufacturer Address
    MONTREAL
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC