ACUSON SC2000 Ultrasound Systems with software version 3 — Class II medical device recall Z-1668-2014

Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-06-04, distributed nationwide. Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5

Recall number	`Z-1668-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc., Mountain View, CA, United States
Recall initiated	2014-04-23
Classified	2014-05-28
Reported by FDA	2014-06-04
Terminated	2015-11-12
Distributed	Nationwide (US)
Countries outside the US	AE, AU, CH, DE, FR, GB, ID, IL, IN, JP, KR, MX, NO, NZ, PH, PL, RO, SA, SE, SG, TR, UA
Quantity	177 units
Reason classes	device malfunction, software
Serial numbers	`400063`, `400108`, `400125`, `400128`, `400142`, `400155`, `400174`, `400176`, `400177`, `400180`, `400200`, `400203`, `400214`, `400218`, `400227`, `400234`, `400247`, `400252`, `400253`, `400263`, `400284`, `400290`, `400297`, `400302`, `400307` and 152 more
Model numbers	`10433816`, `1044966`

Product

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.

Reason for recall

Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1668-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.