FDA-Device2017-05-10Class II
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
Olympus Corporation of the Americas
Hazard
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Sold states
Nationwide
Affected count
863 units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1929-2017Don't want to check this manually?
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