FDA Enforcement
Class II
Terminated
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Recall: Z-3128-2017
·
Reported September 20, 2017
Enforcement
- Recall Number
- Z-3128-2017
- Event ID
- 76905
- 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
- September 20, 2017
- Initiation Date
- March 9, 2015
- Classification Date
- September 12, 2017
- Termination Date
- July 2, 2018
- Address
- 10 Highpoint Dr, N/A, Wayne, NJ, 07470-7431, United States
Description
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Reason
Fujifilm is reporting a corrective action due to an FDA inspection.
Code Info
For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed
Distribution
US Nationwide Distribution
Quantity
260 manuals in total