Recall Z-0112-2014
Fujinon Inc · initiated July 31, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
The firm, FUJIFILM Medical Systems, USA, Inc. (FMSU-ESD) sent an "URGENT-MEDICAL DEVICE CORRECTION (UMDC)" and Customer Acknowledgement forms dated July 31, 2013 to their customers. The letter described the issue with the affected product; instructed customers on how to identify affected units; instructed customers to immediately cease use of the affected units; return affected units to FMSU-ESD for repairs and quality control inspection; and complete and return the attached "Customers Acknowledgement" form to FMSU-ESD, Attn: Regulatory Compliance, via fax to (973) 686-2616 or email: gwalljasper@fujifilm.com. If you have any questions regarding this notice, please do not hesitate to contact Director, Quality and Regulatory Compliance, at (973) 686-2636 or by email: gwalljasper@fujifilm.com.
Details
- Recall number
- Z-0112-2014
- Initiated
- July 31, 2013
- Posted by FDA
- October 30, 2013
- Terminated
- March 4, 2014
- Product code
- FDS – Gastroscope And Accessories, Flexible/Rigid
- Quantity
- 12 Units
- Distribution
- Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
- Recalling firm
- Fujinon Inc, Wayne, NJ