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
    60423
  • Event Risk Class
    Class 2
  • Event Number
    Z-0523-2012
  • Event Initiated Date
    2011-09-15
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105375
  • 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
    Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient. the movement of the swivel arm may also cause an injur.
  • Action
    Siemens Medical Solutions USA, Inc sent a Safety Advisory Notice dated January 8, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The notification included an Addendum to the User Manual. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your operating personnel accordingly. Please ensure that this safety advisory is placed in the System's Operator Manual. Your operating personnel should maintain awareness over an appropriate defined period. Further questions please call (610) 219-4834.

Device

Siemens MAMMOMAT Inspiration
  • Model / Serial
    Model number 10140000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC.
  • Product Description
    MAMMOMAT Inspiration || Full field digital mammographic x-ray system
  • 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