Events

Recall of ACUSON SC2000 Ultrasound imaging 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
    73854
  • Event Risk Class
    Class 2
  • Event Number
    Z-1592-2016
  • Event Initiated Date
    2016-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145184
  • 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
    While imaging with a transesophageal (tee) transducer (z6ms, v5ms, or v7m), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave doppler gate or cursor, the m-mode cursor, the 2d field of view, or the res region of interest with the trackball.
  • Action
    Under Siemens update program US013/16/S a Customer Advisory Notification will be mailed to all affected customers by Certified mail with return receipt beginning March 30, 2016. Letters provide customers information on how to avoid the issue until the software patch is installed.

Device

ACUSON SC2000 Ultrasound imaging system
  • Model / Serial
    Model number 10433816; Serial numbers: 402192 400889 402498 402549 400887 402791 401002 402278 402289 402301 401182 402879 400462 400649 402206 402211 402496 402499 401631 402475 400456 402392 402828 402814 400852 401010 402509 400221 400312 402413 402568 402460 402652 402673 402664 400234 402789 401751 401040 400519 402800 400775 400671 401445 402546 402542 402771 402764 401117 401252 402454 402476 402500 402513 402511 401305 401130.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.
  • Product Description
    ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. || Model number: 10433816.
  • 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