Home › Device types › FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FDA product code FET · Class 2 · Gastroenterology, Urology
369
Registered devices
64,511
Adverse events
8
Recalls
101
510(k) clearances
Devices with this code
COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Suction cleaning adapter — OLYMPUS MEDICAL SYSTEMS CORP.AESCULAP — Aesculap AGGimmi — Gimmi GmbHVIDEO ADAPTER — OLYMPUS MEDICAL SYSTEMS CORP.HD CAMERA HEAD — OLYMPUS MEDICAL SYSTEMS CORP.Channel plug — OLYMPUS MEDICAL SYSTEMS CORP.TipVision™ — SCHÖLLY FIBEROPTIC GmbHSuction cleaning adapter — OLYMPUS MEDICAL SYSTEMS CORP.12G-SDI cable — OLYMPUS MEDICAL SYSTEMS CORP.PROBE DRIVING UNIT — OLYMPUS MEDICAL SYSTEMS CORP.REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd.EVIS-EUS IMAGE CABLE — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.4K CAMERA HEAD — OLYMPUS MEDICAL SYSTEMS CORP.NA — SCHÖLLY FIBEROPTIC GmbHULTRASONIC PROBE — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EXERA GASTROINTESTINAL VIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Channel Connection Tube — OLYMPUS MEDICAL SYSTEMS CORP.n.a. — Karl Storz GmbH & Co. KGXenon Lamp — OLYMPUS MEDICAL SYSTEMS CORP.REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd.NA — SCHÖLLY FIBEROPTIC GmbHVISERA ELITE III VIDEO SYSTEM CENTER — OLYMPUS MEDICAL SYSTEMS CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-21 | Olympus Corporation of the Americas | It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifi |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
| 2018-05-11 | Olympus Corporation of the Americas | Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps d |
| 2018-05-11 | Olympus Corporation of the Americas | Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating |
| 2016-06-20 | Karl Storz Endoscopy | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope a |
| 2015-06-30 | Fujifilm Medical Systems U.S.A., Inc. | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operatio |
| 2015-06-30 | Fujifilm Medical Systems U.S.A., Inc. | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operatio |
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