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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 April 04, 2011
Date Posted September 23, 2011
Recall Status1 Terminated 3 on January 29, 2016
Recall Number Z-3258-2011
Recall Event ID 59825
510(K)Number K080376  
Product Classification Low energy direct current thermal ablation system - Product Code OAB
Product ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804

Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).
Code Information Batch/Serial Numbers: 00120508, 00090508, 00880909, 00371008, 00670709, 00850909, 00890909, 00780709, 00220708, 00300708, 00951009, 00900909, 00800709, 00260708, 00650709, 00690709, 00920909, 00930909, 00770709, 00130508, 01001009.
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Avenue
Queensbury NY 12804
For Additional Information Contact S. Michael Sharp, PhD, FRAPS
518-795-1123
Manufacturer Reason
for Recall		 Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.
FDA Determined
Cause 2		 Component design/selection
Action AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.
Quantity in Commerce 21 units
Distribution Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,
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 = ONCOBIONIC INCORPORATED
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