FDA recall Z-1179-2019

Gyrus ACMI, Inc. · Class II · device

Product

Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

Reason for recall

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Distribution

Nationwide Foreign: Germany,Japan, Singapore

Key facts

Status
Terminated
Initiation date
2019-03-08
Report date
2019-04-24
Termination date
2020-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bartlett, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2019