DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Medical device recall Z-1243-2015. Published in FDA’s Enforcement Report on Mar 11, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 11, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 38 states named
- 153 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
153 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DCAD1300059 DCAD1300063 DCAD1300067 DCAD1300068 DCAD1300072 DCAD1300075 DCAD1300076 DCAD1300086 DCAD1300087 DCAD1300088 DCAD1300089 DCAD1300096 DCAD1300098 DCAD1300107 DCAD1300119 DCAD1300120 DCAD1300122 DCAD1300128 DCAD1300135 DCAD1300136…
Every code shown here, 1,835 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
38 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New York
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 21, 2015.
- FDA classified it on Mar 4, 2015.
- FDA’s Enforcement Report published it on Mar 11, 2015.
- FDA terminated it on May 27, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- iCAD, Inc., of Nashua, NH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.