Fujifilm Recalls Ultrasonic Endoscope Model EG-530UT
Fujifilm Medical Systems is recalling four units of the EG-530UT ultrasonic endoscope following a retrospective review.
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: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or specific hazards, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling four units of the Ultrasonic Endoscope, Model Number EG-530UT. This flexible ultrasonic endoscope is intended to provide ultrasonic images of submucosal and peripheral organs.
The recall was initiated after a retrospective review. The affected units were distributed in the United States to Alabama, Hawaii, and Missouri. Specific unit codes associated with the recall are 1U881A131, 1U88A1A145, and 3U881A005.
The source text does not specify the exact nature of the defect or the specific actions consumers or healthcare providers should take. Users of these devices should contact the manufacturer for further instructions.
The recalled product
- Product
- Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 4
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)
- 1U881A131 1U88A1A145 3U881A005
Distribution
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