Recall Z-0930-2013— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0930-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-18

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2013-01-18, terminated 2013-07-16. It names one FDA 510(k) clearance: K081148. Product: ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.. Reason: On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-18
Terminated: 2013-07-16
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081148 — SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCERSiemens Medical Solutions USA, Inc., Ultrasound DI·cleared 2008-12-22

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 S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

Reason for recall

On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.

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