| Class 2 Device Recall Accu2i pMTA Applicator | |
Date Initiated by Firm | June 05, 2017 |
Create Date | February 05, 2018 |
Recall Status1 |
Terminated 3 on September 11, 2018 |
Recall Number | Z-0526-2018 |
Recall Event ID |
77631 |
510(K)Number | K094021 |
Product Classification |
System, ablation, microwave and accessories - Product Code NEY
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Product | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, 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: 15310411, 15320416, 15340428, 15350430, 15360434, 15380439, 15400449, 15420453, 15430454, 15440459, 15460466, 15470468, 15490476, 15500480, 15520487, 16010488, 16050494, 16070499, 16080502, 16100508, 16120512, 16140517, 16150520, 16170528, 16180530, 16190535, 16210540, 16230549, 16240550, 16250556, 16260561, 16270562, 16300568, 16310572, 16320573, 16350581, 16370590, 16380592, 16390595, 16400599, 16410603, 16420604, 16440611, 16450617, 17010645, 17020649, 17030653, 17040657, 17060662, 17070666, 17090673, 17100675, 17130686*, 17130687. |
Recalling Firm/ Manufacturer |
Angiodynamics, Inc. 603 Queensbury Ave Queensbury NY 12804-7619
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NEY
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