[Recalled] 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: H7871
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | 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 |
|---|---|
| Brand / manufacturer | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1701-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 April 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Angiodynamics Inc. (Navilyst Medical Inc.)
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.