Reported Mar 11, 2015 · Terminated
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
iCAD, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: iCAD, Inc. · 98 Spit Brook Rd · Nashua, NH · 03062-5737
Is this the product you have?
- DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
- Lot codes and dates
153 of 153 codes
DCAD1300059DCAD1300063DCAD1300067DCAD1300068DCAD1300072DCAD1300075DCAD1300076DCAD1300086DCAD1300087DCAD1300088DCAD1300089DCAD1300096DCAD1300098DCAD1300107DCAD1300119DCAD1300120DCAD1300122DCAD1300128DCAD1300135DCAD1300136DCAD1300137DCAD1400140DCAD1400141DCAD1400145DCAD1400146DCAD1400147DCAD1400148DCAD1400153DCAD1400154DCAD1400155DCAD1400156DCAD1400163DCAD1400164DCAD1400165DCAD1400166DCAD1400168DCAD1400169DCAD1400170DCAD1400171DCAD1400173DCAD1400175DCAD1400176DCAD1400177DCAD1400179DCAD1400181DCAD1400182DCAD1400184DCAD1400185DCAD1400186DCAD1400187DCAD1400188DCAD1400191DCAD1400192DCAD1400195DCAD1400197DCAD1400198DCAD1400199DCAD1400200DCAD1400201DCAD1400202
- Amount recalled
- 153 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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