Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0052-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.

Product Classification:

Class II

Date Initiated: July 10, 2013

Date Posted: October 30, 2013

Recall Number: Z-0052-2014

Event ID: 65812

Reason for Recall:

Software issue results in inaccurate 3D image may result in ablation in wrong location.

Status: Terminated

Product Quantity: 26 units

Code Information:

Model# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882

Distribution Pattern:

Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated