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Recall Observatory FDA recall evidence

Device product

Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.

Z-1294-2018

January 01, 2017

Class II

Product summary

Firm
Seiler Instr. & Mfg. Co. Inc.
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

    reason.no_named_rule · v1.0.0

    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.