AngioDynamics Solero Microwave Tissue Ablation — Class II medical device recall Z-1701-2019
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2019-06-12, distributed nationwide. Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk
| Recall number | Z-1701-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2019-04-17 |
| Classified | 2019-05-31 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 178 units |
| Reason classes | software |
| Serial numbers | QBY0001993, QBY0001994, QBY0002001, QBY0002002, QBY0002003, QBY0002004, QBY0002006, QBY0002007, QBY0002008, QBY0002010, QBY0002025, QBY0002026, QBY0002027, QBY0002033, QBY0002034, QBY0002035, QBY0002036, QBY0002037, QBY0002039, QBY0002040, QBY0002041, QBY0002042, QBY0002044, QBY0002051, QBY0002052 and 148 more |
| Model numbers | 12740000D, 12740000USD, H78712740000D0 |
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
Reason for recall
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1701-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.