Medical device recalls Moderate risk

Seiler Instr. & Mfg. Co. Inc. recalls Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.

Recall date
January 1, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1294-2018
FDA classification
Class II
Brand / firm
Seiler Instr. & Mfg. Co. Inc.
Sold / distributed
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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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