Devices

Device Recall FUJINON ED530XT

Model / Serial
All lots/serial numbers
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
FUJINON ED-530XT. || This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
1 Event
- Recall of Device Recall FUJINON ED530XT

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.

Manufacturer Address
Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
Manufacturer Parent Company (2017)
FUJIFILM Holdings Corp.
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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