Fujifilm EPX 2500 Processor Manual and Brochure Recall
Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves documentation errors (mis-labeling) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling the Operation Manual and sales brochure for the Fujifilm Processor EPX 2500 High Definition Endoscopy. The recall is due to incorrect information in the documentation regarding the ED-530XT endoscope.
The Operation Manual and sales brochure incorrectly state that a "super image" is displayed when the ED-530XT endoscope is used with the 2500 processor. In reality, a "standard image" is displayed. The affected documents are identified by codes 2500.0312.00 and 2500.0312.01.
The recall covers multiple units distributed nationwide in the US and Canada. Users of the EPX 2500 Processor should verify their documentation against the recall notice to ensure they are not relying on inaccurate image quality specifications for the ED-530XT endoscope.
The recalled product
- Product
- Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2500.0312.00 and 2500.0312.01
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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