Reported Jun 12, 2019 · Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number:…
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) System(1) Solero
- Generator Refurbished PG Catalog Number12740000D
- UPNH78712740000D0 (2) Solero Generator
- Refurbished US PG Catalog Number12740000USD
- UPNH78712740000USD0
- Lot codes and dates
- Serial Numbers(1)(2) Lot/Serial Number
77 of 77 codes
QBY0002025QBY0002027QBY0001994QBY0001993QBY0002001QBY0002006QBY0002008QBY0002002QBY0002003QBY0002007QBY0002010QBY0002004QBY0002036QBY0002040QBY0002042QBY0002044QBY0002039QBY0002035QBY0002034QBY0002033QBY0002026QBY0002041QBY0002037QBY0002051QBY0002052QBY0002055QBY0002054QBY0002058QBY0002056QBY0002301QBY0002059QBY0002311QBY0002352QBY0002429QBY0002478QBY0002529QBY0002628QBY0002695QBY0002696QBY0002698QBY0002710QBY0002711QBY0002740QBY0002742QBY0002741QBY0002778QBY0002795QBY0002820QBY0002818QBY0002811QBY0002834QBY0002827QBY0002828QBY0002829QBY0002830QBY0002831QBY0002836QBY0002838QBY0002843QBY0002844
QBY0003321; (2) QBY0002306 QBY000261695 of 95 codes
QBY0002279QBY0002294QBY0002295QBY0002293QBY0002305QBY0002284QBY0002280QBY0002299QBY0002298QBY0002296QBY0002278QBY0002290QBY0002287QBY0002281QBY0002289QBY0002277QBY0002285QBY0002378QBY0002377QBY0002384QBY0002380QBY0002386QBY0002387QBY0002388QBY0002394QBY0002390QBY0002392QBY0002391QBY0002396QBY0002398QBY0002395QBY0002399QBY0002472QBY0002482QBY0002483QBY0002484QBY0002485QBY0002518QBY0002521QBY0002522QBY0002524QBY0002525QBY0002528QBY0002535QBY0002536QBY0002537QBY0002538QBY0002539QBY0002540QBY0002541QBY0002544QBY0002550QBY0002551QBY0002561QBY0002562QBY0002567QBY0002568QBY0002577QBY0002578QBY0002579
- Serial Numbers(1)
- Amount recalled
- 178 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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