FDA Device recall Z-2314-2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 1044001…
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 1044001… by Siemens Medical Solutions Usa, citing potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagno….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2314-2015 |
| 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 S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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 using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
Identifiers
| code_info | Model numbers: 10041461, 10440017 S2000 system 10441730 S3000 system 10441701 S1000 system; software version V…Model numbers: 10041461, 10440017 S2000 system 10441730 S3000 system 10441701 S1000 system; software version VC30A, VC30B, VC30C, or VC31A; Serial numbers US: 210104 210121 210187 211161 210103 206479 206595 206701 206726 200313 200394 207073 207099 210186 210811 211030 211147 211148 211477 212130 210509 210510 210540 210702 210714 210911 210957 211031 211097 211259 211368 211441 211444 211454 211511 211612 211689 211694 210172 210173 210178 210188 210257 211439 211071 211438 211453 211459 200245 201227 201256 201387 201389 206039 208718 208772 210112 210229 210260 210689 210798 210821 210903 211270 211577 211645 211660 210607 210622 210653 210662 210703 210729 210742 210744 210747 210753 210788 210795 210924 210930 210931 210934 210947 211047 211067 211121 211549 211581 211641 210119 210677 211483 211289 211300 210226 208637 211364 211385 211710 212156 212157 212167 200624 |
|---|
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-2314-2015%22
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