[Recalled] DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 — A device malfunction may cause the biopsy needle to fail to reach the intended… | FDA 2015-01-21
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 |
|---|---|
| Brand / manufacturer | iCAD, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1243-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 January 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.