Angiodynamics recalls Solero Microwave Tissue Ablation System due to potential delay in procedures causing patient harm. Affected units have specific serial numbers and catalog numbers.
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 because updates to the operator's manual and software may cause delays in procedures, potentially harming patients. This recall affects specific models with known serial numbers and catalog codes.
The system may delay procedures due to software or manual issues, which could lead to patient harm if the procedure isn't completed in a timely manner. This risk is specific to the ablation process and not a general safety issue.
Medical professionals using the Solero MTA System for tissue ablation procedures are most at risk. Patients undergoing these procedures may be affected if the system causes delays.
Check for the Solero Applicator 29cm PG with catalog number 700106003 or 700106003US and serial numbers listed in the recall notice. The product is used for tissue ablation during open procedures.
Check for updated warning statements and software updates that address potential delays in procedures.
The recall indicates potential delays in procedures could cause patient harm, so users should review updated warnings and software updates.
Check the serial numbers and catalog numbers listed in the recall notice to confirm if your unit is affected.
The recall does not specify a deadline for action, but users should review updates immediately to address potential risks.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1704-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1704-2019 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.
