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U.S. Department of Health and Human Services

Class 2 Device Recall Alpha Air 6 ENT Microscope

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  Class 2 Device Recall Alpha Air 6 ENT Microscope see related information
Date Initiated by Firm January 01, 2017
Create Date April 02, 2018
Recall Status1 Open3, Classified
Recall Number Z-1294-2018
Recall Event ID 79362
Product Classification Microscope, surgical - Product Code EPT
Product Alpha Air 6 ENT Microscope

Microscope examination of the human ear, nose, and throat.
Code Information Model Number 6 ENT
Recalling Firm/
Manufacturer		 Seiler Instr. & Mfg. Co. Inc.
3433 Tree Court Industrial Blvd
Saint Louis MO 63122-6617
For Additional Information Contact
314-968-2282
Manufacturer 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.
FDA Determined
Cause 2		 Use error
Action The customer was notified via email on about January 4, 2017. Instructions included that the scope only tips if the user has it extended all the way out and is pulling on the handles of the scope. The end user must not pull on the handles of the scope when it is extended. They were also instructed to educate personnel on this matter. For further questions, please call (314) 968-2282.
Quantity in Commerce 43 units, but 1 affected
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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