Z-1762-2020 Class II Terminated
FDA device recall Z-1762-2020 was initiated by Olympus Corporation of the Americas on March 23, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 30, 2021). Affected quantity: 265 total.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 23, 2020
- Termination Date
- November 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 total
Product Description
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 Pattern
US Nationwide
Code Information
All Serial numbers