FDA Device recall Z-1667-2014
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
- FDA Device
- Class II
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) by Siemens Medical Solutions Usa, citing software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is ad….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1667-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-23 |
| Published | 2014-06-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, MD, MI, MN, MO, NC, NH, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI |
Product
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Reason
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
Identifiers
| code_info | Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400…Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400787 400789 400790 400791 400792 400794 400797 400063 400860 400868 400872 400873 400877 401041 401187 401441 401540 401590 401602 401662 401696 401638 401641 400174 400882 401612 401501 401507 401561 401378 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400803 400821 400570 401010 401020 401235 401252 401564 401611 400998 400999 401601 401648 400979 401625 401631 400234 400312 400972 401433 400336 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400782 400887 400889 401043 401554 400067 401257 401320 401559 401576 401633 401583 400875 400912 400925 400474 400902 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 401608 401618 401669 400630 401558 401587 401644 400227 4004 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1667-2014%22
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