FDA Device recall Z-1243-2015
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 by Icad, citing 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 misloca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1243-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-21 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Icad |
| Distribution | US |
Product
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Reason
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.
Identifiers
| code_info | DCAD1300059 DCAD1300063 DCAD1300067 DCAD1300068 DCAD1300072 DCAD1300075 DCAD1300076 DCAD1300086 DCAD1300087 DC…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1243-2015%22
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