Angiodynamics, Inc. Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Brand
Angiodynamics, Inc.
Lot Codes / Batch Numbers
Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858
Products Sold
Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858
Angiodynamics, Inc. is recalling Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D due to Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can oc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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".
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026