Recall Z-1243-2015— iCAD, Inc.
Class II · Terminated
Class II FDA medical device recall by iCAD, Inc., initiated 2015-01-21, terminated 2016-05-27. It names one FDA 510(k) clearance: K090223. 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..
- Recalling firm
- iCAD, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-21
- Terminated
- 2016-05-27
- Firm location
- Nashua, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.