Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1701-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-04-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1701-2019
Date of alert
2019-04-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics Inc. (Navilyst Medical Inc.)
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.