Angiodynamics recalls Solero Microwave Tissue Ablation System (19cm Applicator) 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, specifically the 19cm applicator, because software updates and manual warnings may cause delays in medical procedures that could harm patients. This recall affects specific units with listed serial numbers and catalog codes.
The system's software and operator manual warnings indicate a risk of delays during medical procedures. This delay could lead to patient harm if the procedure isn't completed in a timely manner, though the exact mechanism isn't specified in the recall.
Healthcare providers using the Solero MTA System for soft tissue ablation procedures are most at risk. Patients undergoing these procedures with the recalled equipment could face potential delays in treatment.
Check for the 19cm Solero Applicator with catalog number 700106002 or 700106002US. Affected units have specific serial numbers listed in the recall notice, including a range of numbers starting with 17200720 and ending with 5448138.
Check the latest version of the operator's manual for updated instructions to reduce procedure delays.
Install any available software updates to address potential delays in the procedure.
This recall is for healthcare providers using the Solero MTA System in medical procedures. Patients are not directly affected by this recall.
Check the catalog number (700106002 or 700106002US) and serial numbers listed in the recall notice, which include specific ranges starting with 17200720 and ending with 5448138.
Review the operator's manual for updated instructions and apply any available software updates to reduce the risk of procedure delays.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1703-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1703-2019 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.
