Events

Recall of MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT

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
    66152
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-29
  • 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 is notifying customers of a potential issue and risk of injury when using the mammomat inspiration acquisition workstation table when it is not fixed to the floor. if the monitors are positioned too far from the table top the acquisition workstation table can become unstable with a risk of it falling over and causing injury to the user.

Device

MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 101 40 000 (Lot serial: 6007)
  • Product Description
    MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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