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U.S. Department of Health and Human Services

Class 2 Device Recall Fujinon/Fujifilm

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  Class 2 Device Recall Fujinon/Fujifilm see related information
Date Initiated by Firm July 31, 2013
Date Posted October 30, 2013
Recall Status1 Terminated 3 on March 04, 2014
Recall Number Z-0112-2014
Recall Event ID 66144
510(K)Number K120446  
Product Classification Gastroscope and accessories, flexible/rigid - Product Code FDS
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.
Code Information Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
Recalling Firm/
Manufacturer		 Fujinon Inc
10 Highpoint Dr
Wayne NJ 07470
For Additional Information Contact Ms. Gina Walljasper
973-686-2636
Manufacturer 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 2		 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: 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.
Quantity in Commerce 12 Units
Distribution Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FDS and Original Applicant = FUJINON, INC.
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