Class II — iCAD, Inc.
| Recalling firm | iCAD INC. |
|---|---|
| Registered facility | ICAD INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 |
| Quantity | 153 devices |
| Distribution | Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and W., and to the countries of : BELGIUM, GERMANY, GREAT BRITAIN, INDIA, ISRAEL, NETHERLANDS and SWITZERLAND. |
| Initiated | 2015-01-21 |
| Classified | 2015-03-04 |
| Terminated | 2016-05-27 |
| Recall number | Z-1243-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — iCAD, Inc. (Z-1243-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70464/
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