Events

Recall of Breast Biopsy Aiming Device

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
    33921
  • Event Risk Class
    Class 2
  • Event Number
    Z-0138-06
  • Event Initiated Date
    2005-10-05
  • Event Date Posted
    2005-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42746
  • 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
    System, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Reason
    If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. this could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. calculation of offset values for the breast biopsy aiming device may be incorrect.
  • Action
    The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual.

Device

Breast Biopsy Aiming Device
  • Model / Serial
    Model number 5728735
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI.
  • Product Description
    Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
  • 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 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA