Events

Recall of HI-ART SYSTEM - KIT-POWER

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

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
    53766
  • Event Risk Class
    II
  • Event Initiated Date
    2010-03-04
  • 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
    During radiotherapy planning the hi-art (ver 4.0 and 4.0.1 software) system updates the imported diagnostic ct couch image portion of the patient's image to the hi-art radiotherapy couch. in some cases the patient's diagnostic ct image is narrower than the hi-art radiotherapy couch image. in these cases the patient's diagnostic ct must be increased in width to accommodate the hi-art radiotherapy couch width. this may result in the patient's regions of interest contours being shifted laterally from the intended position by up to 5mm.

Device

HI-ART SYSTEM - KIT-POWER
  • Model / Serial
    Model Catalog: 101264 (Lot serial: S/N: 10037); Model Catalog: 101264 (Lot serial: S/N: 10169)
  • Product Description
    TOMOTHERAPY HI-ART SYSTEM
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED
  • Manufacturer Address
    MADISON
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Source
    HC