Gyrus ACMI recalls Diego Elite Turbinate Blades Bipolar Blade (BB4040XC) due to potential RF energy activation when used with consoles. Affected units may require replacement.
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 Bipolar Blade (4mm curved, product number BB4040XC) because using them with certain consoles could accidentally activate RF energy. This poses a risk of unintended energy activation during medical procedures.
The blades may accidentally activate RF energy when used with specific consoles, potentially causing unintended tissue heating during medical procedures. This could lead to burns or other complications if the energy is not properly controlled.
Medical professionals using Diego Elite Turbinate Blades with Gyrus ACMI consoles are most at risk. Patients undergoing procedures with these blades could be affected if the RF energy activates unexpectedly.
Check for the product number BB4040XC on the blade packaging. All lot numbers are affected. The blades are used with Gyrus ACMI Diego Elite Consoles for medical procedures.
Look for product number BB4040XC on the blade packaging or label.
The blades may accidentally activate RF energy when used with specific consoles, potentially causing unintended tissue heating during medical procedures.
No, but you should check the product number and contact Gyrus ACMI if you have the affected blades.
Look for product number BB4040XC on the blade packaging or label. All lot numbers are affected.
We’ve drafted a message you can send Gyrus ACMI to request your refund or repair — edit it as you like.
Subject: Recall Z-1185-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1185-2019 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.
