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
    68387
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-12
  • 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
    Potential software issues on mammomat inspiration with system version vb30 and biopsy functionality. the system may freeze and the biopsy cannot be continued in the following situations: the compression force drops e.G. due to patient movement during the active targeting phase or during the targeting phase the inversion tool is used while the scout image is active. as a result of the system freeze the biopsy may have to be repeated.

Device

MAMMOMAT INSPIRATION SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 10660834 (Lot serial: 6639); Model Catalog: 101 40 000 (Lot serial: 6639); Model Catalog: 10660834 (Lot serial: 6537); Model Catalog: 10660834 (Lot serial: 6559); Model Catalog: 101 40 000 (Lot serial: 6559); Model Catalog: 10660834 (Lot serial: 4011); Model Catalog: 101 40 000 (Lot serial: 4011); Model Catalog: 101 40 000 (Lot serial: 2046); Model Catalog: 10660834 (Lot serial: 2046); Model Catalog: 101 40 000 (Lot serial: 6537)
  • 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