Reported Jun 12, 2019 · Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN:…
Angiodynamics Inc. (Navilyst Medical Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics Inc. (Navilyst Medical Inc.) · 10 Glens Falls Tech Park · Glens Falls, NY · 12801-3864
Is this the product you have?
- AngioDynamics Solero
- Microwave Tissue Ablation (MTA) SystemSolero
- Generator PG (1) Catalog Number12740000
- UPNH78712740000 (2)
- Solero Generator US PG Catalog Number12740000US
- UPNH78712740000US0 (3) Solero
- Generator Service Loaner PG Catalog No12740000L
- UPNH78712740000L0 (4) Solero Generator
- Service Loaner US PG Catalog Number12740000USL
- UPNH78712740000USL0
- Lot codes and dates
- Serial Numbers(1)QBY0003145; (2):
229 of 229 codes
QBY0002022QBY0001996QBY0001997QBY0002018QBY0002303QBY0002031QBY0002020QBY0002032QBY0002016QBY0002208QBY0002017QBY0002019QBY0001990QBY0002000QBY0001989QBY0001991QBY0001995QBY0001992QBY0002024QBY0001998QBY0001999QBY0002023QBY0002012QBY0002013QBY0002009QBY0002015QBY0002014QBY0002005QBY0002011QBY0002045QBY0002046QBY0002047QBY0002048QBY0002049QBY0002050QBY0002210QBY0002209QBY0002057QBY0002304QBY0002302QBY0002308QBY0002309QBY0002307QBY0002351QBY0002350QBY0002353QBY0002349QBY0002355QBY0002354QBY0002357QBY0002346QBY0002344QBY0002345QBY0002358QBY0002348QBY0002356QBY0002369QBY0002371QBY0002372QBY0002370
QBY0003111; (3) QBY0002361; (4) QBY0002306 QBY0002616106 of 106 codes
QBY0002288QBY0002300QBY0002297QBY0002291QBY0002282QBY0002292QBY0002283QBY0002286QBY0002376QBY0002375QBY0002379QBY0002383QBY0002381QBY0002382QBY0002385QBY0002389QBY0002393QBY0002397QBY0002471QBY0002516QBY0002517QBY0002519QBY0002520QBY0002526QBY0002527QBY0002534QBY0002542QBY0002543QBY0002552QBY0002553QBY0002545QBY0002546QBY0002547QBY0002549QBY0002554QBY0002569QBY0002570QBY0002611QBY0002612QBY0002613QBY0002615QBY0002618QBY0002619QBY0002662QBY0002663QBY0002664QBY0002668QBY0002665QBY0002669QBY0002670QBY0002671QBY0002682QBY0002683QBY0002684QBY0002687QBY0002690QBY0002704QBY0002758QBY0002759QBY0002763
- Serial Numbers(1)
- Amount recalled
- 314 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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