Angiodynamics recalls Solero Microwave Tissue Ablation System units with specific serial numbers due to updated warnings to reduce potential patient harm from delayed procedures. Affected units include refurbished generators with catalog numbers 12740000D and 12740000USD.
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 certain Solero Microwave Tissue Ablation (MTA) systems that may cause delays in medical procedures, potentially harming patients. This recall involves specific refurbished generator models with listed serial numbers.
The system may delay critical procedures due to outdated software or instructions, which could lead to patient harm if the delay affects treatment timing. Updated warnings and software patches aim to address this risk.
Medical professionals using the Solero MTA system for procedures are most at risk. Patients using these systems during treatments may experience delays in care.
Check for the Solero Generator Refurbished PG with catalog numbers 12740000D or 12740000USD. Affected units have specific serial numbers listed in the recall notice.
Check the operator's manual for updated warnings and software updates to ensure safe procedure timing.
The Solero Microwave Tissue Ablation system is used for medical procedures that require precise tissue ablation, such as in cardiac treatments.
Check if your generator has catalog numbers 12740000D or 12740000USD and a serial number from the list provided in the recall notice.
No, the recall requires reviewing updated warnings and software updates, not immediate discontinuation.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1701-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1701-2019 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.