Gyrus ACMI recalls Diego Elite Turbinate Blades (BB4000SC) due to potential RF energy activation when used with consoles. All units are affected. No remedy specified.
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 (part number BB4000SC) because they can activate RF energy when used with certain consoles. This could cause unintended energy activation, but the recall does not specify a fix or action for consumers.
The blades may activate RF energy when used with Diego Elite consoles, potentially causing unintended tissue heating or damage. This happens due to a compatibility issue between the blades and the console's energy settings.
All owners of Diego Elite Turbinate Blades with part number BB4000SC are affected. Surgeons using these blades with compatible consoles are at risk of unintended RF energy activation.
Check for the part number BB4000SC on the blade packaging or label. All lot numbers are affected, so any Diego Elite Turbinate Blades with this part number should be considered recalled.
Look for part number BB4000SC on the blade packaging or label to confirm if it is recalled.
The recall record does not specify any remedy or fix for this issue.
The recall does not state that immediate action is required, but all affected blades should be checked for the part number.
The blades may activate RF energy when used with Diego Elite consoles, potentially causing unintended tissue heating or damage.
We’ve drafted a message you can send Gyrus ACMI to request your refund or repair — edit it as you like.
Subject: Recall Z-1181-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1181-2019 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.
