Recall Z-1962-2014— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1962-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-03

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2014-06-03, terminated 2016-05-25. It names one FDA 510(k) clearance: K132804. Product: ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.. Reason: There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Terminated: 2016-05-25
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132804 — ACUSON S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro·cleared 2013-10-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

Reason for recall

There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.