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Gendex Dental Systems

Country not established

Devices
2
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2011

    • 29 Dec 2011 Z-1358-2012 Unclassified (pre-2012) Terminated Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly. Distribution: USA including the states of Iowa and Illinois. Submission number: K992610
    • 4 Feb 2011 Z-2040-2011 Unclassified (pre-2012) Terminated There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou Distribution: Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong,…
      Full distribution text Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.
      Submission number: K050255
    • 4 Feb 2011 Z-2041-2011 Unclassified (pre-2012) Terminated There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou Distribution: Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong,…
      Full distribution text Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.
      Submission number: K032355

  • 2010

    • 21 Dec 2010 Z-1373-2011 Unclassified (pre-2012) Terminated The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured starting 5/17/10. North American units manufactured between 12/4/09 and 5/16/10 had functioning AEC buttons, but their manuals stated they were disabled. Units intended for International distribution bet Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, and WI and the countries of Australia, Canada, Germany, New Zealand, Taiwan, and Vietnam.
      Submission number: K050255
    • 20 Dec 2010 Z-1559-2011 Unclassified (pre-2012) Terminated The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate. Distribution: Worldwide distribution: USA and countries including: Australia, Canada and Germany. Submission number: K992610
    • 17 Dec 2010 Z-1248-2011 Unclassified (pre-2012) Terminated The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient. Distribution: California Submission number: K992610

  • 2009

    • 6 Mar 2009 Z-1548-2009 Unclassified (pre-2012) Terminated There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients. Distribution: Nationwide Distribution. Submission number: K060178

Frequently asked questions

How many devices does Gendex Dental Systems have in the registry?

The registry currently lists 2 devices for Gendex Dental Systems. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gendex Dental Systems's devices?

Among its 2 most recently registered devices, Gendex Dental Systems has devices listed in FDA 510(k) (2 devices).

What risk classes do Gendex Dental Systems's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Gendex Dental Systems's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Gendex Dental Systems?

FDA recall records list 7 recalls initiated by Gendex Dental Systems, the most recent initiated on 29 Dec 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Gendex Dental Systems in the registry?

The most recently registered devices listed for Gendex Dental Systems include VIX WIN PRO and ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4.

Generated automatically from registry data and not verified by a human reviewer.