FDAJune 30, 2015device

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

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

The hazard

The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

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 Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. — Recall Details · AllClear