Events

Safety Alert for Stereo Biopsy Device used with Mammomat Inspiration Mammography System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Siemens Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-09-29
  • Event Date Posted
    2014-09-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140929c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: siemens stereo biopsy device used with mammomat inspiration mammography system the australia therapeutic goods administration (tga), has issued a medical device safety alert concerning stereo biopsy device used with mammomat inspiration mammography system [material number: 10140000], manufactured by siemens ltd. the stereo biopsy devices for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted, it could lead to an unintentional patient injury. affected users are advised that in case the needle holder moves unintentionally to press the emergency stop. the manufacturer is recommending inspection of the safety switch before every biopsy until the problem is solved. furthermore, it is preparing a modification of the safety switch. for details, please refer to the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01040-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 sep 2014.

Device

Stereo Biopsy Device used with Mammomat Inspiration Mammography System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Siemens Stereo Biopsy Device used with Mammomat Inspiration Mammography System
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd