Angiodynamics recalls Solero Generator PG units with specific serial numbers to reduce risk of procedure delays. Updated software and manual instructions help ensure safe use during medical procedures.
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 Solero Generator PG units that may cause delays in medical procedures if not updated. This recall is for specific units with listed serial numbers to prevent potential patient harm.
The device may delay procedures if software updates aren't applied, potentially causing patient harm. This is a risk during medical procedures but not an immediate danger.
Medical professionals using the Solero Microwave Tissue Ablation System for procedures. Those with the listed serial numbers are most at risk.
Check your Solero Generator PG unit's serial number against the list provided in the recall notice. The units are identified by specific serial numbers listed in the recall.
Compare your unit's serial number with the list of affected serial numbers provided in the recall notice.
No, the recall does not require immediate discontinuation. Updated software and manual instructions help ensure safe use during procedures.
Check your unit's serial number against the list of affected serial numbers provided in the recall notice.
Check your unit's serial number against the list provided in the recall notice. No immediate action is required beyond verifying your unit's status.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1700-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1700-2019 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.
