FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: 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
- Recall number
- Z-1929-2017
- Recalling firm
- Olympus Corporation of the Americas
- 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
- Status
- Terminated
- Initiated
- 2017-02-10
- Posted
- 2017-02-21
- Terminated
- 2018-05-09
- Reason
- A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
- Root cause
- Device Design
- Action
- A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.
- Quantity
- 863 units
- Distribution
- Nationwide
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K111788"]
- PMA numbers
- not on file
- Product code
- HET
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28