FDAMarch 9, 2015device

Fujifilm Endoscope Model ED-530XT 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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Fujifilm is reporting a corrective action due to an FDA inspection.

What to do

FDA enforcement status: Terminated

Brands named

fujifilm medical systems ufujifilmfujifilm medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Fujifilm Endoscope Model ED-530XT 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. — Recall Details · AllClear