Device product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Z-1907-2026
Product summary
- Event
- Event 98544
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 741 units
- Official record key
device-enforcement:Z-1907-2026
Official wording
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Code information: Model Number: MAJ-2119. UDI Number: 04953170404146. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 14A,15A, 16A, 17A, 18A,1XA, 1YA, 1ZA, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 4XA, 4YA, 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.