Z-2438-2021Class II

Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

Name: Z-2438-2021 Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Creator: Angiodynamics, Inc.
Published: 2021-07-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-07-20 / Terminated / root cause: software

FDA source

Angiodynamics, Inc. began a recall of Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D on 2021-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2438-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-20
Posted: 2021-09-08
Terminated: 2023-03-15
Recalling firm: Boston Scientific Corporation
Product: Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Product code: NEY System, Ablation, Microwave And Accessories
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.
Root cause tag: software
FDA root cause: Software design
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".
Quantity in commerce: 8 OUS
Distribution: Domestic distribution Nationwide. Foreign distribution worldwide.
Product codes and lots: Serial Nos. QBY0002816 QBY0002817 QBY0002348 QBY0002308 QBY0002311 QBY0002711 QBY0002741 QBY0002858

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2438-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2436-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-08
Z-2437-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-08
Z-2438-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-08
Z-2439-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-08

Product code NEY

K162449Class IISolero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. / cleared 2017-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)