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Solero Generator (2021-07-20) — recall 62622

Health Canada — Medical Devices · Canada · 2021-07-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62622
Date of alert
2021-07-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/solero-generator-2021-07-20

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