DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

FDA device recall Z-1243-2015 · posted 2015-03-04 · Terminated

Recall details

Recalling firm

iCAD, Inc.

Reason for recall

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.

Action taken

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 beginning in March 2015. If you need any further information or support concerning this issue, please contact your local Invivo representative: 1-877-Invivo1 (1-877-468-4861, option #3) Invivo apologizes for any inconveniences caused by this problem.

Root cause

Device Design

Status

Terminated

Product code

LLZ

Quantity affected

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,

Date initiated

2015-01-21

Date posted

2015-03-04

Date terminated

2016-05-27

Location

Nashua, NH

Related 510(k) clearances