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SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE(2015-06-30)
- Starting date:
- June 30, 2015
- Posting date:
- September 24, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55024
Affected Products
A. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
Reason
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.
Affected products
A. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
Lot or serial number
>10 contact manufacturer
Model or catalog number
ED-530XT
Companies
- Manufacturer
-
Fujifilm Corporation
26-30 NISHIAZABU, 2 CHOME MINATO-KU
TOKYO-TO
JAPAN