AngioDynamics Solero Microwave Tissue Ablation — Class II medical device recall Z-1700-2019
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-1700-2019 |
|---|---|
| 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 | 314 units |
| Reason classes | software |
| Serial numbers | QBY0001989, QBY0001990, QBY0001991, QBY0001992, QBY0001995, QBY0001996, QBY0001997, QBY0001998, QBY0001999, QBY0002000, QBY0002005, QBY0002009, QBY0002011, QBY0002012, QBY0002013, QBY0002014, QBY0002015, QBY0002016, QBY0002017, QBY0002018, QBY0002019, QBY0002020, QBY0002022, QBY0002023, QBY0002024 and 315 more |
| Model numbers | 12740000, 12740000L, 12740000US, 12740000USL, H78712740000, H78712740000L0, H78712740000US0, H78712740000USL0 |
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
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-1700-2019. 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.