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