SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM — recall 53833
Health Canada — Medical Devices · Canada · 2015-09-24 · Type II
As described by Health Canada — Medical Devices: SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE(2015-06-30)
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Archived by the issuing authority — kept for reference
Reported risk: Fujifilm has become aware of events in which 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. The contrast agent gets sticky and can solidify upon drying, causing the suction button to become lodged.
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