Z-3225-2017 Class II Terminated
FDA device recall Z-3225-2017 was initiated by Fujifilm Medical Systems U.S.A., Inc. on July 21, 2017 and is designated Class II. Reason for recall: 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 mecha… The recall status is terminated (terminated July 12, 2018). Affected quantity: 362 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- July 21, 2017
- Termination Date
- July 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 362 units
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.
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
All lots/serial numbers