Recall Z-1700-2019 ยท NEY System, Ablation, Microwave And Accessories
Angiodynamics Inc. (Navilyst Medical Inc.)
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
| Date | Apr 17, 2019 |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | AngioDynamics issued on April 17, 2019 AngioDynamics initiated a Field Correction by issuing notifications via Federal Express. Consignees are instructed to replace the existing Solero Generator User Manual with the revised version provided with the Notification. Once the replacement has been made, the consignees are instructed to complete and return the Reply Verification Tracking Form, provided in the notification. AngioDynamics will also install a software update to help reduce the incidence of Error 0001 which can occur during initial start-up. This improvement will be implemented on the n |
| Quantity | 314 units |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of AE AT AU BE CA CH CL CO CZ DE DK DZ EG ES FR GB GE GR HK IE IL IN IQ IT LB LT MC MT MX NL NZ PL PT SG TH TR TW VN ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm AngioDynamics, Inc., May 5, 2017 |