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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74525

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 09, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fujifilm Medical Systems U.S.A., Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

Z-2690-2016
Recall number
Z-2690-2016
Initiated
June 09, 2016
Classification
Class II
Status
Terminated
Quantity
2 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

26330437 and 17230408

Distribution pattern

US Distribution to: NC and HI.