Events

Recall of ELEKTA SYNERGY PLATFORM

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
    82519
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-29
  • 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 has identified that if the microswitch within the pcb assembly solenoid limit switch of the middle arm is incorrectly setup there is a potential for an uncontrolled extention of iviewgt / xvi detector arms.

Device

ELEKTA SYNERGY PLATFORM
  • Model / Serial
    Model Catalog: XRT 1402 (Lot serial: N/A); Model Catalog: XRT 1412 (Lot serial: N/A); Model Catalog: XRT 1511 (Lot serial: N/A); Model Catalog: XRT 1501 (Lot serial: N/A); Model Catalog: XRT 20419 (Lot serial: N/A); Model Catalog: XRT 20319 (Lot serial: N/A); Model Catalog: XRT 20219 (Lot serial: N/A); Model Catalog: XRT 20119 (Lot serial: N/A); Model Catalog: XRT 1083 (Lot serial: N/A); Model Catalog: XRT 1093 (Lot serial: N/A)
  • Product Description
    ELEKTA SYNERGY PLATFORM;ELEKTA INFINITY;VERSA HD;ELEKTA AXESSE;PRECISE TREATMENT SYSTEM
  • Manufacturer
    ELEKTA INC.

Manufacturer

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