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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 153
Distribution
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