Events

Recall of Device Recall ACUSON SC2000 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
    79568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1200-2018
  • Event Initiated Date
    2018-03-05
  • Event Date Posted
    2018-03-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162658
  • 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 ecg signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
  • Action
    Undated recall letters were issued via email (if they had an email address for the customer) or via certified mail (if no email address was available) on 3/5/2018.

Device

Device Recall ACUSON SC2000 Ultrasound System
  • Model / Serial
    Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.
  • Product Description
    ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
  • 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