Medical device recalls Moderate risk

Gyrus ACMI, Inc. recalls Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS

Recall date
March 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1186-2019
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 Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS

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