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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84882

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

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Event summary

Timeline bucket
January 21, 2020
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 Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,

Z-1343-2020
Recall number
Z-1343-2020
Initiated
January 21, 2020
Classification
Class II
Status
Terminated
Recalling firm
Hologic, Inc.
Quantity
72

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

Code information

Serial Numbers 81002143175 81002143176 81002143177 81003143178 81003143179 81003143180 81003143181 81003143182 81003143183 81003143184 81003143185 81003143186 81003143187 81003143188 81003143189 81003143190 81003143191 81003143192 81003143193 81003143194 81003143195 81003143196 81003143197 81003143198 81003143199 81003143200 81003143201 81003143202 81003143203 81003143204 81003143205 81003143206 81003143207 81003143208 81003143209 81003143210 81003143211 81003143212 81003143213 81003143214 81003143215 81003143216 81003143217 81003143218 81003143219 81003143220 81003143221A 81003143222A 81003143223 81003143224A 81003143225 81003143226 81003143227 81003143228 81003143229 81003143230 81003143231 81003143232 81003143234 81003143235 81003143236 81003143237 81003143238 81003143239 81003143240 81003143241 81003143242 81003143243 81003143244 81003143245 81003143246A 81003143247

Distribution pattern

Domestic distribution to 14 states: AK AZ CA CO CT DC FL GA IA ID IL MA MO NC NH NJ NY OH SD TX VA. Foreign distribution to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.