FDAApril 17, 2019device

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

angiodynamics inc navilyst medical incangiodynamicsangiodynamics inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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