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Recall Observatory FDA recall evidence

Device product

EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Z-1845-2016

March 15, 2016

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 73640
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1845-2016

Official wording

Reason: New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.

Code information: Models: TJF-160F and TJF-160VF, all serial numbers

Distribution pattern: Nationwide:

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.