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

Recall Z-1700-2019 — AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0

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-1700-2019
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
Barcode (EAN/GTIN): 12740000

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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