Devices

Device Recall Orthoralix 9200 DDE Panoramic & Cephalometric Dental XRay System

Model / Serial
Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901, and all serial numbers.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
Manufacturer
Gendex Dental Systems
1 Event
- Recall of Device Recall Orthoralix 9200 DDE Panoramic & Cephalometric Dental XRay System

Manufacturer

Gendex Dental Systems

Manufacturer Address
Gendex Dental Systems, 901 W Oakton St, Des Plaines IL 60018-1843
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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