Siemens ACUSON S2000 Breast Scanner Recall for Detachment Risk
Siemens is recalling 24 ACUSON S2000 breast scanners because the scanner arm may detach from the column.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states there is a 'low probability' of the arm detaching, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 24 units of the ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are the Boom Welding (#10434968) and Arm Welding (#10434969). The recall covers serial numbers 250157 through 250190.
The recall is being conducted because there is a low probability that the scanner arm will become completely detached from the scanner column. This is a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The affected units were distributed worldwide, including in the United States (specifically Texas and Minnesota), Puerto Rico, and several international countries including China, Germany, the Russian Federation, Saudi Arabia, Taiwan, France, Thailand, and Italy. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.
The recalled product
- Product
- ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers 250157-250190.
Distribution
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