Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
FDA Recall Z-2439-2021 · Posted None
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Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeNEY
Date Initiated2021-07-20
Date Terminated2023-03-15
Product Quantity65 OUS
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.
Firm Action
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".
Root Cause
Software design
Distribution Pattern
Domestic distribution Nationwide. Foreign distribution worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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