FDA Device recall Z-1584-2015
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816 by Siemens Medical Solutions Usa, citing in certain situations, loss of post exercise images can occur in Stress Echo.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1584-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-11 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
Reason
In certain situations, loss of post exercise images can occur in Stress Echo.
Identifiers
| code_info | Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733…Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766 400815 400920 400945 400149 400289 400341 400444 400510 400547 400562 400575 400732 400779 400904 400936 400939 400980 400987 401009 400321 400549 400922 400125 400199 400200 400043 400755 400808 400926 400426 400756 400806 400950 400424 400566 400711 400727 400801 400834 400911 400927 400933 400827 400127 400637 400642 400205 400880 400690 400745 400778 400802 400240 400591 400432 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400863 400869 400871 400910 400937 400938 400724 400846 400973 400219 |
|---|
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-1584-2015%22
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