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U.S. Department of Health and Human Services

Class 2 Device Recall NanoKnife

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  Class 2 Device Recall NanoKnife see related information
Date Initiated by Firm January 20, 2012
Date Posted January 27, 2012
Recall Status1 Terminated 3 on February 10, 2016
Recall Number Z-0918-2012
Recall Event ID 60707
510(K)Number K080202  K102329  
Product Classification Low energy direct current thermal ablation system - Product Code OAB
Product NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101

Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
Code Information Batch codes: 00800709, 00880909, 00870909, 00630609, 00610609, 00470109, 00080508, 00180608, 00050508, 00460109, 00830709, 00240708, 00500209, 00930909, 00430109, 00480209, 00371008, 01210911, 00650709, 00670709, 00690709, 00850909, 00920909, 00820709, 00860909, 00890909, 00940909, 00780709, 00770709, 00760709, 00910909, 00790709, 00361008, 00750709, 00510209, 00450109, 00421208, 00490209, 00530209, 00600609
Recalling Firm/
Manufacturer		 Angiodynamics Worldwide Headquarters
14 Plaza Dr
Latham NY 12110-2166
Manufacturer Reason
for Recall		 Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance.
FDA Determined
Cause 2		 Labeling False and Misleading
Action AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics at 518-798-1360. If customers further distributed the affected product, they should inform those accounts of the field correction. Angiodynamics will also disable the AZE feature during a schedule service visit. For questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.
Quantity in Commerce 40 units
Distribution Nationwide Distribution
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 = OAB and Original Applicant = ANGIODYNAMICS, INC.
510(K)s with Product Code = OAB and Original Applicant = ONCOBIONICS, INC.
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