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U.S. Department of Health and Human Services

Class 2 Device Recall Evis Exera II Duodenovideoscope Olympus TJFQ180V

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  Class 2 Device Recall Evis Exera II Duodenovideoscope Olympus TJFQ180V see related information
Date Initiated by Firm January 08, 2016
Date Posted February 04, 2016
Recall Status1 Terminated 3 on January 09, 2017
Recall Number Z-0757-2016
Recall Event ID 73059
510(K)Number K080403  
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
Product Olympus TJF-Q180V flexible gastrointestinal Duodenoscope

Product Usage:
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Code Information all codes
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact
484-896-5000
Manufacturer Reason
for Recall		 Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.
FDA Determined
Cause 2		 No Marketing Application
Action Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688.
Quantity in Commerce 4436
Distribution US Nationwide Distribution except PR
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 = FDT and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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