Events

Recall of Device Recall ACUSON S2000 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
    51497
  • Event Risk Class
    Class 2
  • Event Number
    Z-1900-2011
  • Event Initiated Date
    2009-01-14
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80551
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    The product has a software problem in which previous patient measurement data gets associated with another patient's image.
  • Action
    The firm, SIEMENS, issued a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label. Should you have any questions, please call (650) 694-5398.

Device

Device Recall ACUSON S2000 Ultrasound System
  • Model / Serial
    All units of this model.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    Siemens brand ACUSON S2000 Ultrasound System with software versions: || VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA || The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
  • 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