Recall Z-0112-2014— Fujinon Inc
Class II · Terminated
Class II FDA medical device recall by Fujinon Inc, initiated 2013-07-31, terminated 2014-03-04. It names one FDA 510(k) clearance: K120446. 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.. Reason: 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..
- Recalling firm
- Fujinon Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-31
- Terminated
- 2014-03-04
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.