Recall Z-1929-2017— Olympus Corporation of the Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2017-02-10, terminated 2018-05-09. It names one FDA 510(k) clearance: K111788. 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. Reason: A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-10
- Terminated
- 2018-05-09
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Data sourced from openFDA. This site is unofficial and independent of the FDA.