Recall Z-1243-2015 ยท LLZ System, Image Processing, Radiological
iCAD, Inc.
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
| Date | Mar 4, 2015 (initiated Jan 21, 2015) |
| 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. |
| Root cause | Device Design |
| Action | iCAD notified Invivo of the recall via letter on January 21, 2015. Invivo sent a Customer Information letter dated January 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters from both Invivo and iCAD (device manufacturer) recommend that DynaCAD Breast Interventional Software not be used with Invivo ds Breast 16 channel lateral grid plate part number 4535-303-31491. Invivo and iCAD are developing DynaCAD Breast Interventional 3.3 that corrects this error and will be available for installation begin |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090223 | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 Icad, Inc., Mar 31, 2009 |