BEUDAMED
    FDA Recall Terminated

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

    Recall: Z-1703-2019 · Initiated April 17, 2019

    Recall

    Recall Number
    Z-1703-2019
    Event Number
    82743
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    NEY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 17, 2019
    Terminated
    June 9, 2020
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

    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

    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 next servicing of the Solero Microwave Tissue Ablation System Generator. Questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time).

    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

    Quantity

    7348