FDA Device recall Z-2321-2015
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option by Siemens Medical Solutions Usa, citing potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral posi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2321-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-25 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Reason
Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
Identifiers
| code_info | Model numbers: 10041461, 10440017 - S2000 system; 10441730 - S3000 system; VTIQ Option - 10439521 and 10439522. Ser…Model numbers: 10041461, 10440017 - S2000 system; 10441730 - S3000 system; VTIQ Option - 10439521 and 10439522. Serial numbers for US: 210104 211147 211148 210257 211071 201387 201389 206511 206574 206592 206619 206732 206832 208718 208772 210931 211483 212156 212157 202555 210055 210061 210423 210426 210427 210629 206049 210032 210128 210334 210361 211742 211334 211156 211165 211215 211180 211183 208220 210666 211158 211338 211425 211611 212064 211091 210343 203158 211278 210692 210748 210777 210010 210479 211550 211551 205213 211123 211448 211709 210993 210164 210839 210954 210961 210672 200113 200140 202137 210034 210215 211777 207390 210505 210521 210861 200695 210759 210761 210764 210768 210769 201673 201979 206346 210265 210488 210573 210631 210667 210783 210825 210843 211124 211167 211174 211260 211316 211319 211320 211499 211513 211627 211635 211636 211637 211639 2116 |
|---|
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-2321-2015%22
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