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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70464

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

Open FDA event record

Event summary

Timeline bucket
January 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
iCAD, 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

DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

Z-1243-2015
Recall number
Z-1243-2015
Initiated
January 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
iCAD, Inc.
Quantity
153 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis.

Code information

DCAD1300059 DCAD1300063 DCAD1300067 DCAD1300068 DCAD1300072 DCAD1300075 DCAD1300076 DCAD1300086 DCAD1300087 DCAD1300088 DCAD1300089 DCAD1300096 DCAD1300098 DCAD1300107 DCAD1300119 DCAD1300120 DCAD1300122 DCAD1300128 DCAD1300135 DCAD1300136 DCAD1300137 DCAD1400140 DCAD1400141 DCAD1400145 DCAD1400146 DCAD1400147 DCAD1400148 DCAD1400153 DCAD1400154 DCAD1400155 DCAD1400156 DCAD1400163 DCAD1400164 DCAD1400165 DCAD1400166 DCAD1400168 DCAD1400169 DCAD1400170 DCAD1400171 DCAD1400173 DCAD1400175 DCAD1400176 DCAD1400177 DCAD1400179 DCAD1400181 DCAD1400182 DCAD1400184 DCAD1400185 DCAD1400186 DCAD1400187 DCAD1400188 DCAD1400191 DCAD1400192 DCAD1400195 DCAD1400197 DCAD1400198 DCAD1400199 DCAD1400200 DCAD1400201 DCAD1400202 DCAD1400203 DCAD1400205 DCAD1400206 DCAD1400207 DCAD1400208 DCAD1400209 DCAD1400210 DCAD1400211 DCAD1400212 DCAD1400213 DCAD1400214 DCAD1400215 DCAD1400216 DCAD1400217 DCAD1400220 DCAD1400221 DCAD1400222 DCAD1400223 DCAD1400224 DCAD1400225 DCAD1400226 DCAD1400227 DCAD1400228 DCAD1400229 DCAD1400230 DCAD1400232 DCAD1400233 DCAD1400235 DCAD1400236 DCAD1400238 DCAD1400239 DCAD1400241 DCAD1400243 DCAD1400244 DCAD1400245 DCAD1400246 DCAD1400250 DCAD1400252 DCAD1400253 DCAD1400254 DCAD1400255 DCAD1400258 DCAD1400259 DCAD1400260 DCAD1400261 DCAD1400262 DCAD1400264 DCAD1400265 DCAD1400266 DCAD1400267 DCAD1400269 DCAD1400270 DCAD1400271 DCAD1400275 DCAD1400277 DCAD1400282 DCAD1400283 DCAD1400285 DCAD1400286 DCAD1400287 DCAD1400291 DCAD1400292 DCAD1400293 DCAD1400296 DCAD1400298 DCAD1400299 DCAD1400302 DCAD1400304 DCAD1400305 DCAD1400306 DCAD1400307 DCAD1400315 DCAD1400316 DCAD1400317 DCAD1400318 DCAD1400319 DCAD1400320 DCAD1400322 DCAD1400324 DCAD1400325 DCAD1400326 DCAD1400327 DCAD1400328 DCAD1400329 DCAD1400330 DCAD1400331 DCAD1400333 DCAD1400334 DCAD1400337 DCAD1400338 DCAD1400339 DCAD1400341 DCAD1500345

Distribution pattern

Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and W., and to the countries of : BELGIUM, GERMANY, GREAT BRITAIN, INDIA, ISRAEL, NETHERLANDS and SWITZERLAND.

Field note

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