FDAFDA · Food and drugs·Recall number Z-0112-2014
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.
Published November 6, 2013 · Recall initiated: July 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fujinon Inc
- Distributor
- Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
- Lot
- Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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