Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PrecisionPoint

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall PrecisionPoint see related information
Date Initiated by Firm January 21, 2015
Date Posted March 04, 2015
Recall Status1 Terminated 3 on May 27, 2016
Recall Number Z-1243-2015
Recall Event ID 70464
510(K)Number K090223  
Product Classification System, image processing, radiological - Product Code LLZ
Product DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Code Information DCAD1300059 DCAD1300063 DCAD1300067 DCAD1300068 DCAD1300072 DCAD1300075 DCAD1300076 DCAD1300086 DCAD1300087 DCAD1300088 DCAD1300089 DCAD1300096 DCAD1300098 DCAD1300107 DCAD1300119 DCAD1300120 DCAD1300122 DCAD1300128 DCAD1300135 DCAD1300136 DCAD1300137 DCAD1400140 DCAD1400141 DCAD1400145 DCAD1400146 DCAD1400147 DCAD1400148 DCAD1400153 DCAD1400154 DCAD1400155 DCAD1400156 DCAD1400163 DCAD1400164 DCAD1400165 DCAD1400166 DCAD1400168 DCAD1400169 DCAD1400170 DCAD1400171 DCAD1400173 DCAD1400175 DCAD1400176 DCAD1400177 DCAD1400179 DCAD1400181 DCAD1400182 DCAD1400184 DCAD1400185 DCAD1400186 DCAD1400187 DCAD1400188 DCAD1400191 DCAD1400192 DCAD1400195 DCAD1400197 DCAD1400198 DCAD1400199 DCAD1400200 DCAD1400201 DCAD1400202 DCAD1400203 DCAD1400205 DCAD1400206 DCAD1400207 DCAD1400208 DCAD1400209 DCAD1400210 DCAD1400211 DCAD1400212 DCAD1400213 DCAD1400214 DCAD1400215 DCAD1400216 DCAD1400217 DCAD1400220 DCAD1400221 DCAD1400222 DCAD1400223 DCAD1400224 DCAD1400225 DCAD1400226 DCAD1400227 DCAD1400228 DCAD1400229 DCAD1400230 DCAD1400232 DCAD1400233 DCAD1400235 DCAD1400236 DCAD1400238 DCAD1400239 DCAD1400241 DCAD1400243 DCAD1400244 DCAD1400245 DCAD1400246 DCAD1400250 DCAD1400252 DCAD1400253 DCAD1400254 DCAD1400255 DCAD1400258 DCAD1400259 DCAD1400260 DCAD1400261 DCAD1400262 DCAD1400264 DCAD1400265 DCAD1400266 DCAD1400267 DCAD1400269 DCAD1400270 DCAD1400271 DCAD1400275 DCAD1400277 DCAD1400282 DCAD1400283 DCAD1400285 DCAD1400286 DCAD1400287 DCAD1400291 DCAD1400292 DCAD1400293 DCAD1400296 DCAD1400298 DCAD1400299 DCAD1400302 DCAD1400304 DCAD1400305 DCAD1400306 DCAD1400307 DCAD1400315 DCAD1400316 DCAD1400317 DCAD1400318 DCAD1400319 DCAD1400320 DCAD1400322 DCAD1400324 DCAD1400325 DCAD1400326 DCAD1400327 DCAD1400328 DCAD1400329 DCAD1400330 DCAD1400331 DCAD1400333 DCAD1400334 DCAD1400337 DCAD1400338 DCAD1400339 DCAD1400341 DCAD1500345 
Recalling Firm/
Manufacturer		 iCAD, Inc.
98 Spit Brook Rd
Suite 100
Nashua NH 03062-5737
For Additional Information Contact
877-8825200
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = ICAD, INC.
-
-