Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection
Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves documentation (manuals) rather than a physical defect in the medical device itself, which aligns with the rubric for 'documentation issues' and 'packaging-only problems' classified as Low severity.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 260 user manuals for the Fujifilm ED-530XT endoscope. This product is a medical endoscope intended for the observation, diagnosis, and treatment of the esophagus, stomach, and duodenum. The recall involves two specific manual codes: 202B1259902B (157 units) and 202B1237697D (103 units).
The recall was initiated as a corrective action resulting from an FDA inspection. The source text does not specify the exact nature of the defect or the specific findings from the inspection, only that the action is required to address issues identified during the review.
The affected manuals were distributed nationwide in the United States. Users of the ED-530XT endoscope should check their documentation for the specific codes listed above. As this recall pertains to the manuals rather than the physical device, users should follow instructions provided by Fujifilm or their medical institution regarding the replacement or correction of the documentation.
The recalled product
- Product
- Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
- Affected units
- 260
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 (3)
- For Manual Code 202B1259902B
- 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D
- 140408-5.0-DT-US2 - 103 manuals were distributed
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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