Health product recall

Solero Generator (2021-07-20)

Starting date:
July 20, 2021
Posting date:
July 29, 2021
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-76105

Last updated:
2021-07-30

Affected Products 

TEMPORARY CYLINDER, MULTI-UNIT

Reason

Angiodynamics, Inc., the manufacturer of the Angiodynamics Solero Microwave Tissue Ablation (MTA), Generator, is conducting a Field Safety Corrective Action (FSCA), to the end user level on specific serial numbers of these devices. The FSCA requires servicing of the Solero MTA Generator to upgrade the software to help reduce the incidence of error code "error 0001", which can occur during system start-up. The software upgrade reduces the risk of potential patient harm that could result from a delay in performing a procedure/treatment.

Affected products

Solero Generator

Lot or serial number

QBY0002816
QBY0002817
QBY0002830
QBY0002843

Model or catalog number

H787127400000
H78712740000D0

Companies
Manufacturer

ANGIODYNAMICS, INC.

26 FOREST STREET

MARLBOROUGH

Massachusetts

UNITED STATES