Events

Recall of Device Recall Alpha Air 6 ENT Microscope

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Seiler Instr. & Mfg. Co. Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79362
  • Event Risk Class
    Class 2
  • Event Number
    Z-1294-2018
  • Event Initiated Date
    2017-01-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162123
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Microscope, surgical - Product Code EPT
  • 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.
  • 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.

Device

Device Recall Alpha Air 6 ENT Microscope
  • Model / Serial
    Model Number 6 ENT
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Alpha Air 6 ENT Microscope || Microscope examination of the human ear, nose, and throat.
  • Manufacturer
    Seiler Instr. & Mfg. Co. Inc.

Manufacturer

Seiler Instr. & Mfg. Co. Inc.
  • Manufacturer Address
    Seiler Instr. & Mfg. Co. Inc., 3433 Tree Court Industrial Blvd, Saint Louis MO 63122-6617
  • Source
    USFDA