Events

Recall of MONACO 5

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
    109923
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-01
  • 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
    When creating 3d plans using dose weighting mode if the user rescales the plan selects "reset" and then changes the wedge angle the plan dose and monitor units (mu) should be returned to the original values before the rescale. instead the system correctly restores the edited wedge field but incorrectly applies the scale reset value again to all other beams in the plan.

Device

MONACO 5
  • Model / Serial
    Model Catalog: MONACO RTP SYSTEM (Lot serial: Version 5.11); Model Catalog: MONACO RTP SYSTEM (Lot serial: Version 5.20)
  • Product Description
    MONACO 5
  • Manufacturer
    ELEKTA INC.

Manufacturer

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