Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling 21 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of unintended RF energy activation in a medical device.
Plain-English summary
Gyrus ACMI, Inc. is recalling 21 units of the Diego Elite Turbinate Blades Bipolar Blade, 4mm curved (Product Number: BB4040XC). The recall covers 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 medical procedures.
The affected products were distributed nationwide as well as to Germany, Japan, and Singapore. Healthcare facilities and users should stop using the affected blades and contact Gyrus ACMI, Inc. for instructions on return or replacement.
The recalled product
- Product
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 21
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 →- HighOlympus Diego Elite Console Recall for Unintended RF Energy Activation
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
- SevereGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Energy Risk
FDA (Devices) · 2019-04-24
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