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
    49589
  • Event Risk Class
    II
  • Event Initiated Date
    2009-08-17
  • 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 radiation treatment the usual data were not visible on the operator station display even though the rad on indicators were active. the treatment was then stopped at around the 4min mark but the system did not mark the treatment as interrupted. when the treatment was re-run the entire treatment was delivered instead of starting at the 4min mark.

Device

HI-ART SYSTEM - KIT-POWER
  • Model / Serial
    Model Catalog: 101264 (Lot serial: 110129); Model Catalog: 101264 (Lot serial: 110009); Model Catalog: 101264 (Lot serial: 101212); Model Catalog: 101264 (Lot serial: 10130); Model Catalog: 101264 (Lot serial: 10072); Model Catalog: 101264 (Lot serial: 10014); Model Catalog: 101264 (Lot serial: 10169); Model Catalog: 101264 (Lot serial: 10037)
  • Product Description
    HI-ART SYSTEM
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

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