FDA Enforcement
Class II
Terminated
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.
Recall: Z-3225-2017
·
Reported October 4, 2017
Enforcement
- Recall Number
- Z-3225-2017
- Event ID
- 78065
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 4, 2017
- Initiation Date
- July 21, 2017
- Classification Date
- September 27, 2017
- Termination Date
- July 12, 2018
- Address
- 10 Highpoint Dr, N/A, Wayne, NJ, 07470-7431, United States
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.
Reason
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
Code Info
All lots/serial numbers
Distribution
Nationwide
Quantity
362 units