Gyrus AC recalls Diego Elite Turbinate Blades (Part No BB2000SA) due to potential RF energy activation when used with consoles. All lot numbers affected.
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Gyrus AC is recalling Diego Elite Turbinate Blades (Part No BB2000SA) because they might activate RF energy when used with their consoles. This could cause injury if not handled properly.
The blades may accidentally activate RF energy when used with the consoles, which could lead to injury. This happens because the blades might not be properly secured or aligned with the console.
Patients using this specific blade type with Gyrus AC Diego Elite consoles are most at risk. The recall affects all units sold with the part number BB2000SA.
Check for the part number BB2000SA on the blade packaging or label. The blades are sold as 'Diego Elite Turbinate Blades: Bipolar Blade, 2mm straight, standard, type A'.
Look for the part number BB2000SA on the blade to confirm it is affected.
The blades may inadvertently activate RF energy when used with Diego Elite consoles, which could cause injury.
The official recall does not specify a remedy, so check with Gyrus AC for guidance.
No, only the specific part number BB2000SA is affected.
We’ve drafted a message you can send Gyrus AC: The record says 'Gyrus ACMI, Inc.' — so we shorten to 'Gyrus AC' for a human-friendly brand name. to request your refund or repair — edit it as you like.
Subject: Recall Z-1179-2019 — Gyrus AC: The record says 'Gyrus ACMI, Inc.' — so we shorten to 'Gyrus AC' for a human-friendly bra Hello, I own a Gyrus AC: The record says 'Gyrus ACMI, Inc.' — so we shorten to 'Gyrus AC' for a human-friendly brand name. that is covered by recall Z-1179-2019 from Gyrus AC: The record says 'Gyrus ACMI, Inc.' — so we shorten to 'Gyrus AC' for a human-friendly brand name.. 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.
