Recall Z-0112-2014 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Fujinon Inc
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.
| Date | Oct 30, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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: gwalljas |
| Quantity | 12 Units |
| Distribution | Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 Fujinon, Inc., Aug 13, 2012 |