FDAMarch 8, 2019device
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
What to do
FDA enforcement status: Terminated
Brands named
gyrus acmigyrus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC2019-03-08
- FDAOlympus Diego Elite Console MDCONS 1002019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS2019-03-08
- FDADiego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS2019-03-08
- FDADiego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS2019-03-08
- FDADiego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA2019-03-08
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