Fujinon Ultrasonic Endoscope Recall for Missing Set Screws
Fujinon Inc is recalling 12 ultrasonic endoscopes due to missing set screws that secure the biopsy inlet port.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that could compromise the integrity of the biopsy port, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Fujinon Inc is recalling 12 units of the Fujinon/Fujifilm Ultrasonic Endoscope (Model EG-530UT2). The recall is due to a manufacturing defect where set screws used to securely attach the Forceps Inlet (biopsy inlet port) to the endoscope were missing.
The affected devices were distributed worldwide, including nationwide in the United States (specifically New Jersey, Pennsylvania, and Virginia) and in Canada. The specific serial numbers involved are NU038A018, NU038A019, NU038A022, NU038A027, NU038A028, and NU038A029.
Healthcare facilities and users should stop using the affected endoscopes and contact Fujinon Inc for further instructions on the recall.
The recalled product
- Product
- Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
- Manufacturer
- Fujinon Inc
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 12
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 (5)
- Model Number EG-530UT2. Serial Numbers: NU038A018
- NU038A019
- NU038A022
- NU038A027
- NU038A028 and NU038A029
Distribution
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