FDA Device recall Z-1700-2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero G…
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero G… by Angiodynamics Navilyst Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1700-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-17 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
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
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
Identifiers
| code_info | Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 Q…Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 QBY0002016 QBY0002208 QBY0002017 QBY0002019 QBY0001990 QBY0002000 QBY0001989 QBY0001991 QBY0001995 QBY0001992 QBY0002024 QBY0001998 QBY0001999 QBY0002023 QBY0002012 QBY0002013 QBY0002009 QBY0002015 QBY0002014 QBY0002005 QBY0002011 QBY0002045 QBY0002046 QBY0002047 QBY0002048 QBY0002049 QBY0002050 QBY0002210 QBY0002209 QBY0002057 QBY0002304 QBY0002302 QBY0002308 QBY0002309 QBY0002307 QBY0002351 QBY0002350 QBY0002353 QBY0002349 QBY0002355 QBY0002354 QBY0002357 QBY0002346 QBY0002344 QBY0002345 QBY0002358 QBY0002348 QBY0002356 QBY0002369 QBY0002371 QBY0002372 QBY0002370 QBY0002368 QBY0002364 QBY0002365 QBY0002363 QBY0002427 QBY0002359 QBY0002362 QBY0002360 QBY0002432 QBY0002430 QBY0002428 QBY0002431 QBY0002433 QBY0002434 QBY0002479 QBY0002480 QBY0002481 QBY0002510 QBY0002511 QBY0002512 QBY0002513 QBY000 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.