Device product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Z-1908-2026
Product summary
- Event
- Event 98544
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 808 units
- Official record key
device-enforcement:Z-1908-2026
Official wording
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Code information: Model Number: MAJ-2138. UDI Number: 04953170404184. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Derived failure modes
-
Unknown
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.