Z-2706-2017 Class II Terminated
FDA device recall Z-2706-2017 was initiated by Fujifilm Medical Systems U.S.A., Inc. on February 17, 2017 and is designated Class II. Reason for recall: Fujifilm is recalling multiple endoscopes after a retrospective review. The recall status is terminated (terminated October 3, 2018). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- February 17, 2017
- Termination Date
- October 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
Reason for Recall
Fujifilm is recalling multiple endoscopes after a retrospective review.
Distribution Pattern
US Distribution to : AL, HI and MO
Code Information
1U881A131 1U88A1A145 3U881A005