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

Recall Z-0386-2018 — ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis o

U.S. FDA — Device Enforcement · United States · 2017-07-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0386-2018
Date of alert: 2017-07-14
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): 76221095

Reported risk: There was a case that the swivel arm went down unintentionally when it was moved up/down.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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