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ScopEYE
MediThinQ Co., Ltd. · Model SE-EDN · UDI-DI 08800182600331
4
510(k) clearances
698
Adverse events
5
Recalls
63
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-21 | Ambu Inc. | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device |
| 2019-06-10 | Olympus Corporation of the Americas | WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds. |
| 2011-10-28 | Olympus America Inc. | Replacement wheels may break off from the base of the cart |
| 2003-10-10 | Smith And Nephew, Inc. Endoscopy Division | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
| 2003-10-10 | Smith And Nephew, Inc. Endoscopy Division | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.