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U.S. Department of Health and Human Services

Class 2 Device Recall Accu2i pMTA Applicator

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  Class 2 Device Recall Accu2i pMTA Applicator see related information
Date Initiated by Firm June 05, 2017
Create Date February 05, 2018
Recall Status1 Terminated 3 on September 11, 2018
Recall Number Z-0529-2018
Recall Event ID 77631
510(K)Number K094021  
Product Classification System, ablation, microwave and accessories - Product Code NEY
Product Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.

Product Usage:
The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
Code Information Lots: 15310412, 15330419, 15340427, 15390446, 15430455, 15440461, 15450463, 15480473, 15490478, 16030490, 16060498, 16130514, 16160524, 16180531, 16240552, 16260560, 16330578, 16350585, 16380593, 16400600, 16420605, 16430609, 16440614, 16460621, 16500638, 16510642, 17010647, 17020650, 17030655, 17050661, 17060664, 17080669, 17110676. 
Recalling Firm/
Manufacturer
Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact Warren Nighan
508-658-7940
Manufacturer Reason
for Recall
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
FDA Determined
Cause 2
Under Investigation by firm
Action URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017. The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce 14,353 units in total
Distribution Worldwide distribution - US Nationwide
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 = NEY and Original Applicant = MICROSULIS MEDICAL LIMITED
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