Recall Z-1860-2016 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Fujifilm Medical Systems U.S.A., Inc.
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
| Date | Dec 23, 2015 |
| Status | Terminated |
| Reason | This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. |
| Root cause | Other |
| Action | Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015. |
| Quantity | 1473 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 Fujinon, Inc., Nov 18, 2004 |