Events

Recall of Siemens Mammomat Inspiration mammography systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

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
    69371
  • Event Risk Class
    Class 2
  • Event Number
    Z-0086-2015
  • Event Initiated Date
    2014-09-18
  • Event Date Posted
    2014-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130325
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Reason
    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 i.
  • Action
    A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.

Device

Siemens Mammomat Inspiration mammography systems
  • Model / Serial
    material #10140000, with serial numbers: 5018 3849 5042
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: NY, VA, and MA.
  • Product Description
    Siemens Mammomat Inspiration mammography systems. || The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA