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

• Reason
• Affected products

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