Recall Z-1294-2018— Seiler Instr. & Mfg. Co. Inc.

Name: FDA recall Z-1294-2018
Creator: U.S. Food and Drug Administration
Published: 2017-01-01

Class II · Ongoing

Class II FDA medical device recall by Seiler Instr. & Mfg. Co. Inc., initiated 2017-01-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.. 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..

Recalling firm: Seiler Instr. & Mfg. Co. Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-01-01
Firm location: Saint Louis, MO, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.