Device recall

Z-0930-2013: ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541…

FDA device recall · Class II · Siemens Medical Solutions USA, Inc.

Key facts

Recall number (Z-number) Z-0930-2013
Recall event 64231
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.
Product code IYO
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Terminated
Termination date Jul 16, 2013
510(k) numbers K081148
FEI number 2936884

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)