Gyrus ACMI recalls Diego Elite Turbinate Blades Bipolar Blade (BB4000SS) due to risk of unintended RF energy activation when used with consoles. All units are affected.
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 straight, part number BB4000SS) because it can activate RF energy unexpectedly when used with their consoles. This could cause injury if the energy is not properly controlled.
The blades may activate RF energy unexpectedly when used with Gyrus ACMI consoles. This could cause unintended tissue damage or injury if the energy is not properly controlled during procedures.
Patients using Diego Elite Turbinate Blades with Gyrus ACMI consoles are affected. Surgeons and dental professionals using these blades are most at risk.
Check for the part number BB4000SS on the blade. All lot numbers are affected, so any Diego Elite Turbinate Blades Bipolar Blade (4mm straight) from Gyrus ACMI are included.
Ensure your console is compatible with the blade before use to prevent unintended RF activation.
The recall states that the blades may activate RF energy unexpectedly when used with consoles, so they are not safe without proper checks.
The recall does not specify a remedy, so you should check console compatibility before use to prevent unintended RF activation.
Yes, the Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, part number BB4000SS is 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-1180-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1180-2019 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.
