Recall Z-1063-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1063-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-12

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2015-01-12, terminated 2015-06-10. It names one FDA 510(k) clearance: K081148. Product: ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.. Reason: There is a low probability the scanner arm will become completely detached from the scanner column..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-12
Terminated: 2015-06-10
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 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

Reason for recall

There is a low probability the scanner arm will become completely detached from the scanner column.

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