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SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM (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 III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55000
Affected Products
A. SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM
Reason
Fujifilm has become aware that the EPX-2500 operation manual and sales brochure incorrectly identify that the ED-530XT endoscope is capable of being used with the EPX- 2500 processor. The operation manual and sales brochure state that when the ED- 530XT endoscope is used with the 2500 processor, a "super image" is displayed, when it is actually a "standard image" that is displayed.
Affected products
A. SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM
Lot or serial number
202B1230408E or earlier
Model or catalog number
EPX-2500
Companies
- Manufacturer
-
Fujifilm Corporation
26-30 NISHIAZABU, 2 CHOME MINATO-KU
TOKYO-TO
JAPAN