Gyrus ACMI Recalls
11 recalls on record · April 18, 2018 to April 24, 2019 · Medical Devices
Recalls by year
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 24, 2019Medical DevicesFDA
Gyrus ACMI, Inc. recalls Olympus Diego Elite Console MDCONS 100
Hazard: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
April 18, 2018Medical DevicesFDA
Gyrus ACMI, Inc. recalls Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Hazard: "Chattering" when cutting burrs are used in bone.