Fujifilm Processor EPX 2500 High Definition Endoscopy recall
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Why was Fujifilm Processor EPX 2500 High Definition Endoscopy recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2500.0312.00 and 2500.0312.01
- Product
- Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- multiple
- Distribution
- Nationwide US and Canada
- Recall date
- September 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)