Device product
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Z-2806-2015
Product summary
- Event
- Event 71706
- Status
- Terminated
- Classification
- Class II
- Quantity
- multiple
- Official record key
device-enforcement:Z-2806-2015
Official wording
Reason: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be 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.
Code information: 2500.0312.00 and 2500.0312.01
Distribution pattern: Nationwide US and Canada
Derived failure modes
-
Unknown
The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be 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.