Recall Z-1929-2017
Olympus Corporation of the Americas · initiated February 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All serial numbers
Reason for recall
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
FDA-determined cause: Device Design
Action taken
A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.
Details
- Recall number
- Z-1929-2017
- Initiated
- February 10, 2017
- Posted by FDA
- February 21, 2017
- Terminated
- May 9, 2018
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Quantity
- 863 units
- Distribution
- Nationwide
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA