Olympus Diego Elite Console Recall for Unintended RF Energy Activation
Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.
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 3/5 (High).
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, and the hazard involves unintended activation of RF energy, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text.
Plain-English summary
Gyrus ACMI, Inc. is recalling the Olympus Diego Elite Console (MDCONS 100) under FDA recall number Z-1178-2019. The recall involves 107 consoles in the United States and 157 consoles in foreign markets, including Germany, Japan, and Singapore. The affected units are identified by specific serial numbers and contain software UIC version 2.3.9.0 and RTC version 00.01.23.
The recall is issued because the consoles may inadvertently permit the activation of the RF energy feature when used with Diego Elite blades. This unintended activation presents a potential safety risk during use.
Healthcare facilities and users should check their console serial numbers against the list provided in the official recall notice. If a unit is affected, users should contact Gyrus ACMI, Inc. for instructions on corrective actions or replacement.
The recalled product
- Product
- Olympus Diego Elite Console MDCONS 100
- Manufacturer
- Gyrus ACMI, Inc.
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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