Device product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Z-1612-2026
Product summary
- Event
- Event 98371
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,929 units
- Official record key
device-enforcement:Z-1612-2026
Official wording
Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Code information: Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.