FDA Device recall Z-0418-2016
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED…
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED… by Fujifilm Medical Systems U, citing A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0418-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-31 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN, WA |
Product
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
Reason
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Identifiers
| code_info | Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107 Model Number: ED-200XT: Serial Number: 8681034…Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107 Model Number: ED-200XT: Serial Number: 8681034 Model Number: ED-250XT: Serial Number: HD077A008 Model Number: ED-310XU: Serial Number: 8591013 Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026 Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022 Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100 Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020 Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2016%22
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