FDA recall Z-1185-2019

Product

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC

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-1185-2019