Reported Nov 6, 2013 · Terminated
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the…
Fujinon Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujinon Inc · 10 Highpoint Dr · Wayne, NJ · 07470
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number EG-530UT2
- Serial Numbers
NU038A018NU038A019NU038A022NU038A027NU038A028 and NU038A029
- Amount recalled
- 12 Units
Where it was sold
Why it was recalled
A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
This product could cause temporary or reversible health problems — stop using it.
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