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Fujifilm Medical Systems U.S.A., Inc. recalls FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifical
Recalled October 4, 2017 · FDA recall Z-3225-2017 · Fujifilm Medical Systems U.S.A
Hazard
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual. · FDA Class II
Units
362 units
Sold at
Nationwide
Description
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
Product
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →