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U.S. Department of Health and Human Services

Class 2 Device Recall Solero Microwave Tissue Ablation (MTA) System

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 Class 2 Device Recall Solero Microwave Tissue Ablation (MTA) Systemsee related information
Date Initiated by FirmJuly 20, 2021
Create DateSeptember 08, 2021
Recall Status1 Terminated 3 on March 15, 2023
Recall NumberZ-2438-2021
Recall Event ID 88444
510(K)NumberK162449 
Product Classification System, ablation, microwave and accessories - Product Code NEY
ProductSolero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Code Information Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactSaleem Cheeks
518-795-1174
Manufacturer Reason
for Recall		Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
FDA Determined
Cause 2		Software design
ActionOn July 20, 2021, the firm initiated the recall by issuing Urgent Voluntary Medical Device Recall letters to affected consignees. Customers were informed of the software upgrade. Customers were asked to return their generators to AngioDynamics for service. The firm's Hardware Service Department will contact you to schedule the upgrade, which may include the shipment of a replacement generator to your facility if needed to be used during the upgrade of your devices. In the interim, while this upgrade is being scheduled, you may continue to use the Solero generator and are instructed to adhere to the following Warning in the current product labeling (User Manual): WARNING: Do not initiate the procedure/anesthesia until the applicator has been connected, primed, and the generator status bar indicates "Ready".
Quantity in Commerce8 OUS
DistributionDomestic distribution Nationwide. Foreign distribution worldwide.
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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