Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Recalled by Siemens Medical Solutions USA, Inc. Due to Software issue results in inaccurate 3D image may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc. directly.
Affected Products
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.
Quantity: 26 units
Why Was This Recalled?
Software issue results in inaccurate 3D image may result in ablation in wrong location.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report