FDAFDA · Food and drugs·Recall number Z-1179-2019
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Published April 24, 2019 · Recall initiated: March 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gyrus ACMI, Inc.
- Distributor
- Nationwide Foreign: Germany,Japan, Singapore
- Lot
- All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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