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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics

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 Class 2 Device Recall AngioDynamicssee related information
Date Initiated by FirmApril 17, 2019
Create DateMay 31, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall NumberZ-1702-2019
Recall Event ID 82743
510(K)NumberK162449 
Product Classification System, ablation, microwave and accessories - Product Code NEY
ProductAngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Code Information Serial Numbers: (1) 16470624 16480627 16490631 17120679 17120680 17120681 17120682 17150698 17160702 17160703 17180710 17180711 17190712 17190714 17200716 17220734 17220735 17240736 17280752 17280753 17290760 17310767 17310768 17320770 17330775 17340776 17340777 17350783 17360786 17370787 17370789 17370791 17390798 17390800 17400803 17410807 17420815 17430819 17420818 17430822 17430824 17440825 17440831 17450832 17450833 17450834 17450835 17450836 17460838 17460839 17460841 17460840 17460842 17460843 17470851 17470852 17480856 17480857 17480861 17480862 5365914 5370556 5371648 5375252 5377978 5379637 5392050 5392051 5392052 5392053 5396938 5399659 5399855 5399856 5399857 5401850 5399859 5399858 5426382 5426386 5426383 5426404 5426384 5428527 5442207 5442208 5442212 5442211 5442213 5442214 5444677 5448140 5450578 5450579 5450845 5450844; (2): Lot/Serial Number 17200719 17220729 17220727 17220728 17220733 17240739 17250740 17250742 17260744 17260746 17270748 17270750 17280751 17320769 17320772 17360785 17380792 17380793 17400804 17440827 17440826 17470848 5341431 5347402 5347400 5349199 5353212 5356008 5359010 5361185 5389956 5379727 5396939 5394387 5394388 5398904 5404489 5426396 5428526 5426393 5430888 5430889 5426385 5442210 5444676 5448137 5448135  
FEI Number 3017892510
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information ContactSame
518-792-4112
Manufacturer Reason
for Recall		Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
FDA Determined
Cause 2		Device Design
ActionAngioDynamics issued on April 17, 2019 AngioDynamics initiated a Field Correction by issuing notifications via Federal Express. Consignees are instructed to replace the existing Solero Generator User Manual with the revised version provided with the Notification. Once the replacement has been made, the consignees are instructed to complete and return the Reply Verification Tracking Form, provided in the notification. AngioDynamics will also install a software update to help reduce the incidence of Error 0001 which can occur during initial start-up. This improvement will be implemented on the next servicing of the Solero Microwave Tissue Ablation System Generator. Questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time).
Quantity in Commerce10580
DistributionWorldwide distribution - US Nationwide distribution and countries of AE AT AU BE CA CH CL CO CZ DE DK DZ EG ES FR GB GE GR HK IE IL IN IQ IT LB LT MC MT MX NL NZ PL PT SG TH TR TW VN ZA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NEY
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