Gyrus ACMI recalls Diego Elite Malleable 4mm Standard Monopolar Blades (Product Code MM4000SS) due to risk of unintended RF energy activation. Affected units may cause injury if used improperly.
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 Malleable 4mm Standard Monopolar Blades (Product Code MM4000SS) because they can accidentally activate RF energy when used with certain consoles. This poses a risk of injury if the blades are not used correctly.
The blades can accidentally activate RF energy when used with Gyrus ACMI consoles. This unintended activation could cause injury during medical procedures if the energy is not properly controlled.
Users of Diego Elite Malleable blades with Gyrus ACMI consoles are affected. Surgeons and medical professionals using these blades for procedures are most at risk.
Check for Diego Elite Malleable 4mm Standard Monopolar Blades with Product Code MM4000SS. All lot numbers are affected.
Verify the product code is MM4000SS on the blade packaging or label.
The recall does not require immediate discontinuation; users can continue using the blades with caution but should follow the action steps.
The blades may accidentally activate RF energy when used with Gyrus ACMI consoles, potentially causing injury during medical procedures.
Check for Product Code MM4000SS 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-1187-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1187-2019 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.
