Siemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images
Siemens is recalling 26 Acuson SC2000 ultrasound systems because a software issue causes inaccurate 3D images, which may lead to ablation in the wrong location.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (ablation in the wrong location), which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 26 Acuson SC2000 volume imaging ultrasound systems at software version 3.0. The recall is due to a software issue that results in inaccurate 3D images. This defect may result in ablation being performed in the wrong location.
The affected units were distributed worldwide, including nationwide in the United States (specifically in IL, PA, AZ, OR, OH, NY, CO, TX, and CA) and in France, Germany, Japan, Portugal, Saudi Arabia, Taiwan, and Turkey. The specific serial numbers for the affected units are listed in the agency's recall record.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue. Consumers should not use the affected systems for clinical diagnosis purposes until the issue is resolved.
The recalled product
- 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 26
Distribution
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