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FDAFDA · Food and drugs·Recall number Z-1294-2018

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

Published April 11, 2018 · Recall initiated: January 1, 2017

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Seiler Instr. & Mfg. Co. Inc.
Distributor
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.
Lot
Model Number 6 ENT
Risk classification
Class II
Area (FDA)
device
Country
United States

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