ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number

FDA device recall Z-1959-2015 · posted 2015-07-02 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

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.

Action taken

Siemens sent an Customer Safety Advisory Notification on May 29,2015, to all affected customers. The letter identified the product the problems and the action needed to be taken by the customer. Customer Safety Advisory notifications inform users of the potential issue with the ACUSON SC2000 systems with software versions between VA16! and VA30A and the Stress Echo feature. Letters describe the steps that result in the potential loss of data and suggest that the following steps be taken to remedy the situation: 1. Select Stress Echo Selection 2. If applicable relabel the clips for all Stages and Views 3. Do not return to Stress Echo Selection to select additional relabeled clips. The issue will be resolved in an upcoming software release for customers who did not receive the original software update. Until the necessary repairs have been completed, all personnel in the Organization who need to be aware of the issue should be notified. For further questions please call (650) 694-5398.

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

573 devices

Distribution

Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia

Date initiated

2015-05-29

Date posted

2015-07-02

Date terminated

2017-03-09

Location

Mountain View, CA