Gyr:us ACMI recalls Diego Elite Turbinate Blades (BB4040SC) due to potential RF energy activation when used with consoles. Affected units may cause unintended activation risks.
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Gyrus ACMI is recalling Diego Elite Turbinate Blades (model BB4040SC) because they can accidentally activate RF energy when used with certain consoles. This could lead to unintended activation risks during medical procedures.
The blades may activate RF energy features unintentionally when used with specific consoles. This could cause unintended activation during medical procedures, potentially leading to unintended tissue effects.
Medical professionals using Diego Elite Turbinate Blades with Olympus Diego Elite Consoles are affected. Those who use the blades with consoles not properly configured are at higher risk.
Check for the product number BB4040SC on the blade packaging. The blades are sold with Olympus Diego Elite Consoles and are used in medical procedures.
Ensure the Diego Elite Turbinate Blades are used only with Olympus Diego Elite Consoles that have the correct RF settings.
The product number is BB4040SC.
No, but you should check console compatibility before use.
The blades may activate RF energy features unintentionally when used with certain consoles, potentially causing unintended tissue effects.
We’ve drafted a message you can send Gyrus ACMI to request your refund or repair — edit it as you like.
Subject: Recall Z-1183-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1183-2019 from Gyrus ACMI. 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.
