Fujifilm EPX 2500 Operation Manual Recalled for Incorrect Endoscope Specifications
Fujifilm is recalling 60 EPX 2500 Operation Manuals and sales brochures that incorrectly identify the ED-530XT endoscope's image capabilities.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving minor labeling errors in documentation that do not pose a direct risk of serious injury or death, fitting the criteria for moderate severity.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 60 copies of the Fujinon/Fujifilm Processor EPX 2500 Operation Manual and sales brochures. The recall covers specific part numbers (202B1230408A through 202B1230408E) distributed nationwide in the US and Canada.
The recall is due to a labeling error in the documentation. The manuals and brochures incorrectly state that the ED-530XT endoscope, when used with the EPX-2500 Processor, displays a "super image." In reality, the device displays a "standard image." This mislabeling could lead to incorrect expectations regarding the equipment's performance.
Healthcare facilities and consumers who possess these specific manuals or brochures should stop using them for reference regarding the ED-530XT endoscope's image capabilities. Fujifilm is the recalling firm responsible for this Class II recall.
The recalled product
- Product
- Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
- Affected units
- 60
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 (4)
- Part Numbers: 202B1230408A
- 202B1230408B
- 202B1230408C
- 202B1230408D and 202B1230408E
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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