—#188680

Product

Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD

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. QBY0002546 QBY0002517 QBY0002525 QBY0002562 QBY0002669 QBY0002569 QBY0002382 QBY0002682 QBY0002561 QBY0002567 QBY0002580 QBY0002398 QBY0002379 QBY0002612 QBY0002708 QBY0002527 QBY0002758 QBY0002552

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 #188680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.