FDA recall Z-1762-2020
Olympus Corporation of the Americas · Class II · device
Product
Olympus Pleuravideoscope, Model LTF-160
Reason for recall
There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
Distribution
US Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2020-03-23
- Report date
- 2020-04-29
- Termination date
- 2021-11-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1762-2020