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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66195

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

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Event summary

Timeline bucket
September 06, 2013
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

Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography

Z-2301-2013
Recall number
Z-2301-2013
Initiated
September 06, 2013
Classification
Class II
Status
Terminated
Recalling firm
Hologic, Inc.
Quantity
62 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may

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

Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

Code information

Software versions 5.0.x and 5.1.x

Distribution pattern

Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.