[Recalled] AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and ac |
|---|---|
| Brand / manufacturer | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1704-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 April 2019 |
| EAN / barcode | 16480626 |
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.