FDA recall Z-1181-2019

Gyrus ACMI, Inc. · Class II · device

Product

Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC

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-1181-2019