Recall Z-2436-2021 ยท NEY System, Ablation, Microwave And Accessories
Angiodynamics, Inc.
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
| Date | Jul 20, 2021 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 16 US, 2 OUS |
| Distribution | Domestic distribution Nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm AngioDynamics, Inc., May 5, 2017 |