Events

Recall of MEVATRON LINEAR ACCELERATORS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE 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
    25259
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-24
  • 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
    Siemens became aware of an incident with a linear accelerator oncor where an autosequence was set up with a treatment management system. during the autosequence the gantry collided with the patient's head while moving. the patient received a wound on the head that resulted in skin injuries but no further damage. the user provided a detailed report in which he described that a mistake was made when selecting the beams for autosequence. the user error caused the unintended motion and hence the injury.

Device

MEVATRON LINEAR ACCELERATORS
  • Model / Serial
    Model Catalog: 04504200 (Lot serial: 3645); Model Catalog: 01940035 (Lot serial: 3645); Model Catalog: 04504200 (Lot serial: 3641); Model Catalog: 01940035 (Lot serial: 3641); Model Catalog: 04504200 (Lot serial: 3382); Model Catalog: 01940035 (Lot serial: 3382); Model Catalog: 8139789 (Lot serial: 5414); Model Catalog: 01940035 (Lot serial: 3919); Model Catalog: 04504200 (Lot serial: 3919); Model Catalog: 01940035 (Lot serial: 2559); Model Catalog: 04504200 (Lot serial: 2559); Model Catalog: 5857912 (Lot serial: 3799); Model Catalog: 5857912 (Lot serial: 3865); Model Catalog: 7360717 (Lot serial: 5037); Model Catalog: 7360717 (Lot serial: 5041); Model Catalog: 7360717 (Lot serial: 5324)
  • Product Description
    MEVATRON LINEAR ACCELERATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC