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

Recall Z-2690-2016 — FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and d

U.S. FDA — Device Enforcement · United States · 2016-06-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2690-2016
Date of alert: 2016-06-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fujifilm Medical Systems U.S.A., Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 26330437

Reported risk: If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.

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

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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