Recalls / —
—#142937
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.
- FDA product code
- FDT — Duodenoscope And Accessories, Flexible/Rigid
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K080403
- Affected lot / code info
- all codes
Why it was recalled
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.
Root cause (FDA determination)
No Marketing Application
Action the firm took
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.
Recalling firm
- Firm
- Olympus Corporation of the Americas
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610
Distribution
- Distribution pattern
- US Nationwide Distribution except PR
Timeline
- Recall initiated
- 2016-01-08
- Posted by FDA
- 2016-02-04
- Terminated
- 2017-01-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.