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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-1704-2019
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 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 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) 16480626 17150699 17160704 17170705 17170706 17310766 17370790 17380795 17390797 17420814 17420817 17430823 17460844 17460847 17470850 5377356 (2) 17200721 17210722 17220730 17220731 17220732 17250743 17270749 17300765 17320771 17380794 17400805 17420816 17440830 17470849 5346596 5355835 5385267 5392055 5392056 5416590 5426407 5446902  
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 Commerce1846
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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