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.
Reported: October 30, 2013 Initiated: July 10, 2013 #Z-0052-2014
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.
Reason for Recall
Software issue results in inaccurate 3D image may result in ablation in wrong location.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 26 units
- Distribution
- 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.
- Location
- Mountain View, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 26 units.
Why was this product recalled? ▼
Software issue results in inaccurate 3D image may result in ablation in wrong location.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2013. Severity: Moderate. Recall number: Z-0052-2014.
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