# Washing Case Maj-827

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/washing-case-n6178901>
- Manufacturer: [Olympus Medical Systems Corporation](https://devicerts.com/manufacturers/olympus-medical-systems-corporation) (FDA registration: Japan)
- Name in the registry: WASHING CASE MAJ-827
- Device class: Class II (US FDA)
- FDA product code: FEB
- GMDN: Sterilizer/disinfector rack (62151)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 04953170438301 · listed 2023-04-22 · status: Listed (GUDID: not in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K120357 · decision 2012-12-20 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K103264 · decision 2011-02-23 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1613-2026 · Class II · ongoing · initiated 2026-02-12: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Z-0873-2026 · Class II · ongoing · initiated 2025-10-31: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Z-0874-2026 · Class II · ongoing · initiated 2025-10-31: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Z-1009-2024 · Class II · ongoing · initiated 2024-01-16: Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
- Z-2447-2023 · Class II · ongoing · initiated 2023-07-12: The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
- Z-2342-2023 · Class II · ongoing · initiated 2023-05-26: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
- Z-2343-2023 · Class II · ongoing · initiated 2023-05-26: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
- Z-0138-2017 · Class II · terminated · initiated 2016-06-23: New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

## Identity

- Trade name: WASHING CASE [FDA GUDID (AccessGUDID)]
- Generic name: Sterilizer/disinfector rack [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: MAJ-827 [FDA GUDID (AccessGUDID)]; N6178901 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04953170438301 [FDA GUDID (AccessGUDID)]
- FDA product code: FEB [FDA GUDID (AccessGUDID)]
- GMDN term: Sterilizer/disinfector rack (62151) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 876.1500 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Washing Case Maj-827, Olympus Medical Systems Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/washing-case-n6178901 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/washing-case-n6178901.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/washing-case-n6178901
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.