Angiodynamics recalls Solero Microwave Tissue Ablation System (14cm applicator) due to potential delay in procedures causing patient harm. Check serial numbers listed for affected units.
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Angiodynamics is recalling its Solero Microwave Tissue Ablation (MTA) System, specifically the 14cm applicator, because outdated software or instructions might cause delays in medical procedures that could harm patients. This recall affects specific serial numbers and catalog numbers listed in the official notice.
The system's outdated software or instructions might cause delays in completing medical procedures. This delay could lead to patient harm if the procedure is interrupted or requires immediate action.
Medical professionals using the Solero MTA System for tissue ablation procedures are most at risk. Patients undergoing these procedures with the recalled applicators could face potential delays in treatment.
Check for the Solero 14cm applicator with catalog number 700106001 or 700106001US. Affected units have specific serial numbers listed in the recall notice, including numbers starting with 17200719 and others.
Review the list of serial numbers provided in the recall notice to determine if your device is affected.
This recall affects medical professionals using the Solero MTA System for tissue ablation procedures, not patients directly.
The Solero 14cm applicator with catalog numbers 700106001 and 700106001US is being recalled.
Compare your device's serial number to the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1702-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1702-2019 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
