The Recall Desk
HighFDA (Devices)·Z-1243-2015·Announced 2015-03-11

iCAD Recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of incorrect diagnosis due to biopsy mislocation, which fits the rubric criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2. The recall involves 153 devices distributed nationwide in the United States and in Belgium, Germany, Great Britain, India, Israel, the Netherlands, and Switzerland.

The recall is due to a device malfunction that 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. This may result in an incorrect diagnosis.

Healthcare facilities and consumers who have these software versions should contact iCAD, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Manufacturer
iCAD, Inc.
Category
Medical Device — Software
Hazard
Affected units
153

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Related recalls

Same hazard · incorrect diagnosis

See all →