Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Energy Risk
Gyrus ACMI, Inc. is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the hazard involves unintended RF energy activation in a medical device, which constitutes a significant injury risk.
Plain-English summary
Gyrus ACMI, Inc. is recalling Diego Elite Turbinate Blades, specifically the Bipolar Blade, 2mm straight, standard, type A (Part No BB2000SA). The recall involves 502 units distributed nationwide and in Germany, Japan, and Singapore. All lot numbers are affected.
The recall is being issued because Olympus Diego Elite Consoles may inadvertently permit the activation of the RF energy feature when used with these specific Diego Elite blades. This unintended activation presents a potential safety hazard during medical procedures.
Healthcare providers and facilities that have received these blades should stop using them immediately. They should contact Gyrus ACMI, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 502
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 Activation Risk
FDA (Devices) · 2019-04-24
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