FDAApril 17, 2019device

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0

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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AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0 — Recall Details · AllClear