Events

Recall of Device Recall 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
    65487
  • Event Risk Class
    Class 2
  • Event Number
    Z-1694-2013
  • Event Initiated Date
    2013-02-28
  • Event Date Posted
    2013-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119086
  • 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
    Firm became aware of an unintended behavior when using the mammomat inspiration. the possibility exists that a malfunction may occur during stereo or tomo acquisitions if the tomo clutch was incorrectly adjusted. although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. firm released update instructions xp031/12/s for this iss.
  • Action
    Siemens issued an Update Instructions XP031/12/S by letter to the affected customers. For affected sites, a Siemens Service Engineer will inspect the unit and make any adjustments needed. Following the inspection and adjustments, a proper calibration will be completed. For questions call 610-448-3237 and 610-446-4634.

Device

Device Recall Siemens Mammomat Inspiration
  • Model / Serial
    Model number 10140000, serial numbers 3118, 3243 and 3309
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States Nationwide Distribution in the states of ND, OH and SC.
  • Product Description
    Siemens Mammomat Inspiration - full-field digital mammography || Product Usage: Mammography
  • 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