FDAFDA · Food and drugs·Recall number Z-0052-2014
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.
Published October 30, 2013 · Recall initiated: July 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software issue results in inaccurate 3D image may result in ablation in wrong location.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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