Solero MTA System and Solero Microwave Tissue Ablation Applicator (2019-04-16)
- Starting date:
- April 16, 2019
- Posting date:
- May 10, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69838
Last updated: 2019-05-10
Affected Products
A. Solero MTA System
B. Solero Microwave Tissue Ablation Applicator
Reason
AngioDynamics, Inc. is conducting a field safety corrective action (FSCA), to the end user level on the Solero Microwave Tissue Ablation (MTA) system, generators and applicators. The instructions and warnings have been clarified to ensure the Solero system is functioning properly prior to starting a procedure.
Affected products
A. Solero MTA System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- H787127400000
Companies
- Manufacturer
-
Navilyst Medical, Inc.
26 Forest Street
Marlborough
01752
Massachusetts
UNITED STATES
B. Solero Microwave Tissue Ablation Applicator
Lot or serial number
More than 1000 numbers, contact manufacturer.
Model or catalog number
- H7877001060010
- H7877001060020
- H7877001060030
Companies
- Manufacturer
-
Navilyst Medical, Inc.
26 Forest Street
Marlborough
01752
Massachusetts
UNITED STATES