Events

Recall of Siemens MAMMOMAT Inspiration

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
    68224
  • Event Risk Class
    Class 2
  • Event Number
    Z-1638-2014
  • Event Initiated Date
    2014-04-25
  • Event Date Posted
    2014-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127169
  • 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
    There is a potential and possible hazard to the user when using the mammomat inspiration pc monitor at the control desk, in that the holder of the pc monitor can break causing an unstable monitor to fall causing possible serious injury.
  • Action
    A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.

Device

Siemens MAMMOMAT Inspiration
  • Model / Serial
    (Material number 10549894) with serial numbers 5000 through 5029.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of GA, FL, NY, NV, and MA.
  • Product Description
    MAMMOMAT Inspiration. || Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
  • 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