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Siemens Medical Solutions USA, Inc. recalls Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, In
Recalled October 30, 2013 · FDA recall Z-0052-2014 · Siemens Medical Solutions USA
Hazard
Software issue results in inaccurate 3D image may result in ablation in wrong location. · FDA Class II
Units
26 units
Sold at
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.
Description
Software issue results in inaccurate 3D image may result in ablation in wrong location.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →