FDA Devices recall · Reported March 20, 2013
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 acquisition of the breast image.
On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Siemens Medical Solutions USA, Inc. recalled ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed… - a moderate-severity action.
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed… was recalled by Siemens Medical Solutions USA, Inc. in March 20, 2013. Reason: On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.. Check the official notice for the remedy. Verify recall #Z-0930-2013 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc. issued this moderate-severity FDA Devices recall-On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges..
- Moderate
- severity level
- Class II
- classification
- March 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0930-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 acquisition of the breast image.
Reason for recall
On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0930-2013 |
| Date reported | March 20, 2013 |
| Date initiated | January 18, 2013 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Firm location | Mountain View, CA |
| Affected scope | 214 affected devices |
| Distribution | Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, M… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0930-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026