Z-0112-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2013
- Initiation Date
- July 31, 2013
- Termination Date
- March 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 Units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Code Information
Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029