FDA Device recall Z-1959-2015
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option by Siemens Medical Solutions Usa, citing when performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1959-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. 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. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Reason
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
Identifiers
| code_info | Model number 10433816 between software version VA16A and VA30A: US Serial numbers: 400930 401216 401375 401343 40…Model number 10433816 between software version VA16A and VA30A: US Serial numbers: 400930 401216 401375 401343 401049 400538 401115 400572 400464 401346 400196 401030 401246 400222 400455 400457 401090 401078 400318 401345 400668 400667 401158 400545 401022 401184 401308 401141 401311 400462 400467 400460 400461 401383 400466 401149 401300 400479 400493 400519 400861 400117 401070 400907 400740 400552 400454 401204 400530 400814 400818 400835 400900 400810 400811 401155 401156 400736 401279 401280 400220 400221 400742 400913 401351 400069 400326 400123 400137 400197 400234 400152 401322 401323 401327 400967 400974 400884 400795 401265 401266 401258 400848 400874 400883 400175 401348 400759 400226 400885 400757 400472 400536 401278 400236 400629 400640 401384 400800 400768 400775 400679 400680 400269 400483 400484 401234 401256 401003 401013 401014 400886 400890 400898 400 |
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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-1959-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.