Recall Z-2269-2018 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Olympus Corporation of the Americas
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
| Date | May 11, 2018 |
| Status | Terminated |
| Reason | Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection. |
| Root cause | Under Investigation by firm |
| Action | Firm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business |
| Quantity | 994 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K853585 | OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS Olympus Corp., Jan 21, 1986 |