FDA-Device2016-06-08Class II
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Fujifilm Medical Systems U.S.A., Inc.
Hazard
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Sold states
Nationwide Distribution.
Affected count
882 units
Manufactured in
10 Highpoint Dr, N/A, Wayne, NJ, United States
Products
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1862-2016Don't want to check this manually?
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