Home › FUJIFILM CORPORATION › FUJIFILM
FUJIFILM
FUJIFILM CORPORATION · Model EC-760R-V/L · UDI-DI 04547410358681
1
510(k) clearances
80,660
Adverse events (54 deaths)
12
Recalls
70
Facilities
Description
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-31 | Olympus Corporation of the Americas | High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from |
| 2024-09-18 | Olympus Corporation of the Americas | To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified |
| 2023-07-27 | Aomori Olympus Co., Ltd. | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| 2023-07-27 | Aomori Olympus Co., Ltd. | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| 2022-04-22 | Olympus Corporation of the Americas | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections |
| 2017-02-17 | Fujifilm Medical Systems U.S.A., Inc. | Fujifilm is recalling multiple endoscopes after a retrospective review. |
| 2016-08-15 | Pentax of America Inc | PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs. |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.