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Recall Observatory FDA recall evidence

Device product

Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

Z-1929-2017

February 10, 2017

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 76488
Status
Terminated
Classification
Class II
Quantity
863 units
Official record key
device-enforcement:Z-1929-2017

Official wording

Reason: A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

Code information: All serial numbers

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.