Gyrus ACMI recalls Diego Elite Blades Monopolar 4mm Straight TIA (Product Code MB4000SS) 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 Blades Monopolar, 4mm Straight, TIA blades (Product Code MB4000SS) because they may activate RF energy when used with certain consoles. This could cause unintended energy exposure during procedures.
The blades may activate RF energy features when used with Diego Elite Consoles, potentially causing unintended energy exposure during medical procedures. This could lead to tissue damage or other complications if not properly controlled.
Users of Diego Elite Consoles with these blades are affected. Medical professionals using these blades for procedures are most at risk.
Check for the Product Code MB4000SS on Diego Elite Blades Monopolar, 4mm Straight, TIA blades. All lot numbers are affected.
Look for Product Code MB4000SS on the blade packaging or label.
The recall does not specify a stop-use instruction, so you can continue using them if you follow the product's safety guidelines.
The recall states that RF energy may activate inadvertently, potentially causing unintended energy exposure during procedures.
Check for Product Code MB4000SS 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-1186-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1186-2019 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.
