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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81700

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

Open FDA event record

Event summary

Timeline bucket
December 06, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hologic, 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

I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Z-0685-2019
Recall number
Z-0685-2019
Initiated
December 06, 2018
Classification
Class II
Status
Terminated
Recalling firm
Hologic, Inc.
Quantity
337 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

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

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

Code information

Model Number: ASY-08109 UDI Number: 15420045512016 All units

Distribution pattern

Nationwide Foreign: Australia Austria Belgium Brazil Canada China Colombia Ecuador Egypt France Germany Greece Hong Kong India Ireland Israel Italy Japan Korea, Republic of Kuwait Malaysia Mexico Netherlands Pakistan Peru Poland Portugal Saudi Arabia Singapore Slovakia South Africa Spain Switzerland Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom