Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling 13 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with compatible consoles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall involving a risk-of-harm product where injury has not yet been reported corresponds to a High severity score.
Plain-English summary
Gyrus ACMI, Inc. is recalling 13 units of the Diego Elite Turbinate Blades Bipolar Blade, 4mm curved (Product Number: BB4040SC). The recall affects all lot numbers of this specific product.
The recall is being issued because Olympus Diego Elite Consoles may inadvertently permit the activation of the RF energy feature when used with these Diego Elite blades. This unintended activation presents a potential safety risk during use.
The affected products were distributed nationwide as well as in Germany, Japan, and Singapore. Healthcare facilities and users should stop using the affected blades and contact Gyrus ACMI, Inc. for further instructions or a return.
The recalled product
- Product
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Gyrus ACMI, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Gyrus ACMI, Inc.
See all →- SevereGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
- SevereGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Energy Risk
FDA (Devices) · 2019-04-24
- HighGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
- HighGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
- HighGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
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