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

Recall Z-2219-2025 — ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

U.S. FDA — Device Enforcement · United States · 2025-06-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2219-2025
Date of alert: 2025-06-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: FUJIFILM Healthcare Americas Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 01547410297546

Reported risk: Devices had an unapproved slabbing software function enabled for use.

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.

Recall Z-2219-2025 — ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

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