DynaLOC Breast Interventional Planning Software Versions 3 — Class II medical device recall Z-1243-2015
Terminated recall by iCAD, Inc., reported 2015-03-11, distributed nationwide. A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming
| Recall number | Z-1243-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | iCAD, Inc., Nashua, NH, United States |
| Recall initiated | 2015-01-21 |
| Classified | 2015-03-04 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2016-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, GB, IL, IN, NL |
| Quantity | 153 devices |
| Reason classes | device malfunction |
Product
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1243-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.