Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1063-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-01-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1063-2015
Date of alert: 2015-01-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10434730

Reported risk: There is a low probability the scanner arm will become completely detached from the scanner column.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1063-2015 — 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.

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