Device product

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.

Z-2778-2015

June 30, 2015

Class II

Product summary

Firm: Fujifilm Medical Systems U.S.A., Inc.
Event: Event 71695
Status: Terminated
Classification: Class II
Quantity: 256 units
Official record key: device-enforcement:Z-2778-2015

Official wording

Reason: 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.

Code information: ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681

Distribution pattern: Distributed in the US and Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.