Recall of TREATMENT TABLE FOR ELEKTA PRECISE

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

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
    33447
  • Event Risk Class
    II
  • Event Initiated Date
    2009-01-28
  • Event Country
  • 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
    An issue has been identified that in desktop pro release 6.1 6.2 and 7.0 sites with precise table there a possible error (of up to 8mm) in the reported table longitudinal position.

Device

  • Model / Serial
    Model Catalog: MRT 5121 (Lot serial: Axesse NPSS 133801 to 133860); Model Catalog: MRT 5111 (Lot serial: Axesse NPSS 133801 to 133860); Model Catalog: MRT 5071 (Lot serial: Axesse NPSS 133801 to 133860); Model Catalog: MRT 5121 (Lot serial: Hexapod ready 133801 to 133860); Model Catalog: MRT 5111 (Lot serial: Hexapod ready 133801 to 133860); Model Catalog: MRT 5071 (Lot serial: NEBATO 124001 TO 124515); Model Catalog: MRT 5121 (Lot serial: CHINA 125001 TO 126001); Model Catalog: MRT 5111 (Lot serial: CHINA 125001 TO 126001); Model Catalog: MRT 5071 (Lot serial: CHINA 125001 TO 126001); Model Catalog: MRT 5121 (Lot serial: NEBATO 124001 TO 124515); Model Catalog: MRT 5111 (Lot serial: NEBATO 124001 TO 124515); Model Catalog: MRT 5071 (Lot serial: Hexapod ready 133801 to 133860)
  • Product Description
    Elekta Precise Treatment Table
  • Manufacturer

Manufacturer

  • Manufacturer Address
    CRAWLEY
  • Manufacturer Parent Company (2017)
  • Source
    HC