Events

Recall of ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)

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
    68197
  • Event Risk Class
    Class 2
  • Event Number
    Z-1668-2014
  • Event Initiated Date
    2014-04-23
  • Event Date Posted
    2014-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127127
  • 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
    Potential malfunction due to a software issue for acuson sc2000 ultrasound systems using software version 3.5 (va35) when using the stress echo feature which could cause the need for the study to be repeated.
  • Action
    Siemens sent a Consumer Safety Advisory Notification letter on April 23, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the stress echo feature with software version .5. For studies acquired with systolic-only captures: review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system, please contact your local Customer Service representative. Foreign distributors will implement distribution of the field correction to their customers. For questions regarding this recall call 650-694-5398.

Device

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
  • Model / Serial
    ACUSON SC2000 model number: 10433816; Stress Echo Feature model number: 1044966 Serial numbers - USA: 400290 400425 400439 400441 400443 400447 401176 400787 400789 400790 400791 400792 400794 400797 400063 400877 401187 401441 401590 401602 401638 400174 401612 401501 401507 401561 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400570 401010 401020 401235 401252 401564 401611 400998 400999 400979 401625 401631 400234 400312 400972 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400887 400889 401043 401257 401559 401576 400474 400902 400860 400875 400912 400925 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 ROW:  400652 400733 400737 400746 401437 401443 401478 401495 401650 400546 401506 401371 401325 401581 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 400125 400200 401434 401626 401615 400155 400180 400307 400704 401428 401541 401624 401004 401546 401519 401627 400247 400263 400511 401045 400497 400284 400252 401502 400655 400214 400253 400836 400840 401118 400218 400990 401127 401180.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.
  • Product Description
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
  • 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