Events

Recall of Device Recall ACUSON S2000 ABVS Ultrasound System

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
    58504
  • Event Risk Class
    Class 2
  • Event Number
    Z-2150-2011
  • Event Initiated Date
    2011-03-28
  • Event Date Posted
    2011-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99480
  • 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 doppler ultrasonic - Product Code IYN
  • Reason
    The weld connecting the abvs arm to the system base has the potential to fail, causing the arm to fall off of the unit.
  • Action
    Siemens Medical Solutions USA, Inc. initiated the recall via phone calls and e-mail on March 28, 2011, to all affected customers, informing them of the affected product and providing instructions on the recall. Three units S/N 250171, 250173, and 250177 were to be removed and shipped back to Siemens. Siemens Service personnel were to be dispatched to the customer sites to perform validated stress test on units S/N 250157, 250162, 250163, 250164, 250166, 250167, and 250169 at customer sites. For questions regarding this recall call 650-694-5993.

Device

Device Recall ACUSON S2000 ABVS Ultrasound System
  • Model / Serial
    Serial Numbers Affected: 250171, 250173, 250177, 250157, 250162, 250163, 250164, 250166, 250167 and 250169
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.
  • Product Description
    Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; || Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA || The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA