Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
- Recall date
- March 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1182-2019
- FDA classification
- Class II
- Brand / firm
- Gyrus ACMI, Inc.
- Sold / distributed
- Nationwide Foreign: Germany,Japan, Singapore
Why it was recalled
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
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