Recall Z-3225-2017 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Fujifilm Medical Systems U.S.A., Inc.
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.
| Date | Jul 21, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On July 21, 2017, Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division distributed Urgent Medical Device Correction and Removal notices & Field Action Verification Forms to their U.S. Consignees by USPS certified mail. Fujifilm Medical Systems will contact all customers that have the duodenoscope by October 2017, with details for returning the device for replacement parts. This field action allows continued use of the current device until you are contacted by a sales representative for replacement parts as early as October 2017. While the remediation of the scopes will take approximatel |
| Quantity | 362 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152257 | Fujifilm Duodenoscope Model ED-530XT Fujifilm Medical Systems U.S.A, Inc., Jul 21, 2017 |