Device product
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Z-1294-2018
Product summary
- Event
- Event 79362
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43 units, but 1 affected
- Official record key
device-enforcement:Z-1294-2018
Official wording
Reason: The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.
Code information: Model Number 6 ENT
Distribution pattern: Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, NV, OK, TX., and to the countries of : Canada, China, Ecuador, England, Greece, Guatemala, Jordan, Lebanon, Mexico, Romania, Russia, South Korea, Taiwan, Japan and United Arab Emirates.
Derived failure modes
-
Unknown
The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.