Reported Sep 30, 2015 · Terminated
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 10 Highpoint Dr · Wayne, NJ · 07470-7431
Is this the product you have?
- Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
- Lot codes and dates
- Part Numbers
202B1230408A202B1230408B202B1230408C202B1230408D and 202B1230408E
- Part Numbers
- Amount recalled
- 60
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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