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Open, Classified

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

FDA Recall Z-1294-2018 · Posted None

Recalling FirmSeiler Instr. & Mfg. Co. Inc.
Recall StatusOpen, Classified
Product CodeEPT
Date Initiated2017-01-01
Product Quantity43 units, but 1 affected

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.

Firm 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.

Root Cause

Use error

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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