Z-0112-2014 Class II Terminated
FDA device recall Z-0112-2014 was initiated by Fujinon Inc on July 31, 2013 and is designated Class II. 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 endoscop… The recall status is terminated (terminated March 4, 2014). Affected quantity: 12 Units.
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