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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-2439-2021
Recall Event ID 88444
510(K)NumberK162449 
Product Classification System, ablation, microwave and accessories - Product Code NEY
ProductSolero Generator PG, Item No. H78712740000, Catalog No. 12740000
Code Information Serial Nos. QBY0002623 QBY0002629 QBY0002857 QBY0002830 QBY0002843 QBY0002431 QBY0002715 QBY0002717 QBY0002731 QBY0002732 QBY0002744 QBY0002745 QBY0002363 QBY0002631 QBY0002834 QBY0001999 QBY0002000 QBY0002303 QBY0002353 QBY0002368 QBY0002432 QBY0002575 QBY0002653 QBY0002782 QBY0002783 QBY0002784 QBY0002004 QBY0002346 QBY0002576 QBY0002655 QBY0002680 QBY0002694 QBY0002709 QBY0002712 QBY0002791 QBY0002794 QBY0001991 QBY0001996 QBY0002036 QBY0002058 QBY0002703 QBY0002826 QBY0002833 QBY0002510 QBY0002624 QBY0002048 QBY0002012 QBY0002015 QBY0002481 QBY0002513 QBY0002531 QBY0002532 QBY0002812 QBY0002821 QBY0002738 QBY0002739 QBY0002564 QBY0002656 QBY0002657 QBY0002676 QBY0002014 QBY0002355 QBY0002563 QBY0002630 QBY0002743
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 Commerce65 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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