Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1243-2015 — DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

U.S. FDA — Device Enforcement · United States · 2015-01-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1243-2015
Date of alert
2015-01-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
iCAD, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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