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Recall Observatory FDA recall evidence

Device 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.

Z-0757-2016

January 08, 2016

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 73059
Status
Terminated
Classification
Class II
Quantity
4436
Official record key
device-enforcement:Z-0757-2016

Official wording

Reason: 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.

Code information: all codes

Distribution pattern: US Nationwide Distribution except PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.