Events

Recall of Device Recall Mammo Test

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
    51449
  • Event Risk Class
    Class 2
  • Event Number
    Z-1318-2009
  • Event Initiated Date
    2009-01-21
  • Event Date Posted
    2009-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80301
  • 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
    x-ray guided stereotactic biopsy system - Product Code JAQ
  • Reason
    Table may unintentionally lift during procedure.
  • Action
    Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009.

Device

Device Recall Mammo Test
  • Model / Serial
    Serial numbers 10102, 10103, 10105, and 10106
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA distribution to IL, NY, SC, and WA
  • Product Description
    Mammo Test Model number 10144185, x-ray guided stereotactic biopsy 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