Recall of MOBILETT XP HYBRID MOBILE X-RAY GENERATOR WITH BATTERY OPERATION

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

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
    20114
  • Event Risk Class
    III
  • 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
    Maufacturer will install protective covers over the electronics in order to avoid short circuits caused by objects or liquids dropping onto the electronics boards. systems with batteries (mobilett xp hybrid) will have a 0protective fuse installed between minus of the batteries and chassis in order to avoid short circuits in the battery terminals and cables.

Device

  • Model / Serial
    Model Catalog: 018 18 454 (Lot serial: 1026); Model Catalog: 018 18 454 (Lot serial: 2025); Model Catalog: 018 18 454 (Lot serial: 2013); Model Catalog: 018 18 454 (Lot serial: 2007); Model Catalog: 018 18 454 (Lot serial: 2006); Model Catalog: 018 18 454 (Lot serial: 1337); Model Catalog: 018 18 454 (Lot serial: 1321); Model Catalog: 018 18 454 (Lot serial: 1320); Model Catalog: 018 18 454 (Lot serial: 1313); Model Catalog: 018 18 454 (Lot serial: 1274); Model Catalog: 018 18 454 (Lot serial: 1255); Model Catalog: 018 18 454 (Lot serial: 1243); Model Catalog: 018 18 454 (Lot serial: 1222); Model Catalog: 018 18 454 (Lot serial: 1182); Model Catalog: 018 18 454 (Lot serial: 1132); Model Catalog: 018 18 454 (Lot serial: 1125); Model Catalog: 018 18 454 (Lot serial: 1120); Model Catalog: 018 18 363 (Lot serial: 2035); Model Catalog: 018 18 363 (Lot serial: 1127)
  • Product Description
    MOBILETT XP HYBRID X-RAY GENERATOR
  • Manufacturer

Manufacturer

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