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.
Recall
- Recall Number
- Z-0418-2016
- Event Number
- 72258
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- FEI Number
- 2431293
- Product Code
- FDT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 31, 2015
- Terminated
- March 21, 2018
- Address
- 10 Highpoint Dr, Wayne, NJ, 07470-7431
Description
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.
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm. Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ 07470 or via fax to 973-633-8818. Customers with questions were instructed to contact their Fujifilm sales representative. For questions regarding this recall call 973-686-2482
US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
79 units (US) and 985 units (Internationally)