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 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
    28771
  • Event Risk Class
    I
  • Event Initiated Date
    2011-09-01
  • 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
    Lowering the swivel arm with "object table" while an operator's or a patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. the movement of the swivel arm may also cause an injury. during a biopsy examination the swivel arm of the system might be tilted to somewhere between +15 and -15 degrees and when starting the examination to acquire stereo images the swivel arm may automatically move between +15 to -15 degrees. this movement may cause body parts to be pinched or otherwise injured particularly with seated or recumbent patients.

Device

MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC