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Terminated

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

FDA Recall Z-1929-2017 · Posted 2017-02-21

Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeHET
Date Initiated2017-02-10
Date Terminated2018-05-09
Product Quantity863 units

Reason for Recall

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

Firm Action

A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111788ENDOEYE HD IIOlympus America, Inc. · 2012-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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