Gyrus ACMI recalls Diego Elite Turbinate Blades Bipolar Blades (BB4040XS) due to potential 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 Blades (model BB4040XS) because they may activate RF energy when used with certain consoles. This could cause unintended tissue damage during medical procedures.
The blades may activate RF energy when used with specific consoles, causing unintended tissue damage during medical procedures. This happens because the console's RF energy feature can be inadvertently triggered by the blade's design.
Medical professionals using Diego Elite Turbinate Blades with Olympus Diego Elite Consoles are most at risk. Patients undergoing procedures with these blades could face unintended tissue damage.
Check for the product number BB4040XS on the blade packaging or label. All lot numbers are affected, so any Diego Elite Turbinate Blades Bipolar Blades with this model number should be recalled.
Verify the product number on the blade is BB4040XS to confirm it is recalled.
The blades may inadvertently activate RF energy when used with specific consoles, potentially causing unintended tissue damage during medical procedures.
No immediate stop is required, but you should check if your blades are recalled and follow the action steps to ensure safety.
Check the product number on the blade to confirm it is BB4040XS. If recalled, contact Gyrus ACMI for guidance on next steps.
We’ve drafted a message you can send Gyrus ACMI to request your refund or repair — edit it as you like.
Subject: Recall Z-1184-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1184-2019 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.
