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Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical
Recalled September 20, 2017 · FDA recall Z-3129-2017 · Fujifilm Medical Systems U.S.A
Hazard
Fujifilm is conducting a corrective action due to an FDA inspection. · FDA Class II
Units
260 manuals in total
Sold at
US Nationwide Distribution
Description
Fujifilm is conducting a corrective action due to an FDA inspection.
Product
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →