—#188681

Product

Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US

FDA product code: NEY — System, Ablation, Microwave And Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K162449
Affected lot / code info: Serial Nos. QBY0002693 QBY0002376 QBY0002765 QBY0002380 QBY0002763 QBY0002662 QBY0002570 QBY0002683 QBY0002551 QBY0002618 QBY0002006 QBY0002293 QBY0002578 QBY0002666 QBY0002378 QBY0002375 QBY0002283 QBY0002539 QBY0002762 QBY0002681 QBY0002690 QBY0002389 QBY0002518 QBY0002670 QBY0002395 QBY0002687 QBY0002613 QBY0002664 QBY0002759 QBY0002780

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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".

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern: Domestic distribution Nationwide. Foreign distribution worldwide.

Timeline

Recall initiated: 2021-07-20
Terminated: 2023-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188681. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.