Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD
FDA device recall Z-1929-2017 · posted 2017-02-21 · Terminated
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 863 units
- Distribution
- Nationwide
- Date initiated
- 2017-02-10
- Date posted
- 2017-02-21
- Date terminated
- 2018-05-09
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOEYE HD II (K111788) | Olympus America, Inc. | 2012-01-13 |