FDA-Device2015-09-09Class II
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Panoramic Rental Corp.
Hazard
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Sold states
Worldwide distribution: US (nationwide) all 50 states, including Puerto Rico; and countries of Antigua, Armenia, Aruba, Austria, Canada, China, Colombia, Ecuador, Egypt, England, France, Germany, Greece, Haiti, Honduras, Indonesia, Japan, Kenya, Lithuania, Mexico, Panama, Saudi Arabia, Singapore, Taiwan, Turkey, UAE, Uganda, Venezuela, Vietnam, and Virgin Islands.
Affected count
7885
Manufactured in
4321 Goshen Rd, N/A, Fort Wayne, IN, United States
Products
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2015Don't want to check this manually?
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