FDA recall Z-1178-2019
Gyrus ACMI, Inc. · Class II · device
Product
Olympus Diego Elite Console MDCONS 100
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-1178-2019