Recall Z-1700-2019— Angiodynamics Inc. (Navilyst Medical Inc.)
Class II · Terminated
Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2019-04-17, terminated 2020-06-09. It names one FDA 510(k) clearance: K162449. Product: 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 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0. Reason: 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.
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-17
- Terminated
- 2020-06-09
- Firm location
- Glens Falls, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.