Siemens ACUSON S2000 ABVS Scanner Recalled for Sharp Transducer Edges
Siemens is recalling 214 ACUSON S2000 ABVS systems because the transducer pod may contain sharp edges that could cause injury.
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 involves a risk-of-harm product (sharp edges) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 214 ACUSON S2000 Automated Breast Volume Scanner (ABVS) systems, model number 10042541. The recall is due to a defect where the inside of the transducer pod may contain sharp edges.
The affected devices were distributed worldwide, including in the United States (specifically West Virginia and Ohio) and numerous international locations. Only systems manufactured prior to October 30, 2012, that include the ABVS module are affected.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The source text does not specify a specific consumer action for individual patients, as these are professional medical devices.
The recalled product
- Product
- ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Category
- Medical Device — Ultrasound
- Hazard
- Affected units
- 214
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 (2)
- however only those systems that include the ABVS module
- part number 10042541 are affected. Manufactured prior to 10/30/2012.
Distribution
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