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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics NanoKnife Disposable Single Electrode Probes

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  Class 2 Device Recall AngioDynamics NanoKnife Disposable Single Electrode Probes see related information
Date Initiated by Firm April 24, 2020
Create Date October 07, 2021
Recall Status1 Terminated 3 on September 20, 2022
Recall Number Z-0073-2022
Recall Event ID 88679
510(K)Number K150089  
Product Classification Low energy direct current thermal ablation system - Product Code OAB
Product AngioDynamics NanoKnife Disposable Single Electrode
Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Code Information lot 5577754
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact Saleem Cheeks
518-798-1174
Manufacturer Reason
for Recall		 Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product.
Quantity in Commerce 37
Distribution Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
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.
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