Events

Recall of Device Recall ACUSON S2000 Automated Breast Volume Scanner (ABVS);

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
    64231
  • Event Risk Class
    Class 2
  • Event Number
    Z-0930-2013
  • Event Initiated Date
    2013-01-18
  • Event Date Posted
    2013-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115642
  • 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, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    On some acuson s2000 abvs systems, the inside of the transducer pod may contain sharp edges.
  • Action
    Siemens sent a Customer Safety Advisory notification letter to Siemens Service Personnel on January 18, 2013 and which would be provided to all affected sites during their visit to correct the problem. The notification identified the product, the problem and the action to be taken. The local Customer Service Engineer will perform the test at their site. If the system passes the test, no further action is required. If the ABVS pod fails the inspection, the Service Engineer will correct the sharp edge. For questions regarding this recall call 650-694-5398.

Device

Device Recall ACUSON S2000 Automated Breast Volume Scanner (ABVS);
  • Model / Serial
    Model number 10042541 - AVBS module.  Note: the S2000 system part number is 10041461, however only those systems that include the ABVS module, part number 10042541 are affected. Manufactured prior to 10/30/2012.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 || Distributed by Siemens Medical Solutions USA Inc. || business Unit: Ultrasound. || The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA