FDA-Device2016-10-12Class II
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Panoramic Rental Corp.
Hazard
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
Sold states
US Nationwide Distribution including Puerto Rico
Affected count
13,340
Manufactured in
4321 Goshen Rd, N/A, Fort Wayne, IN, United States
Products
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 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-0016-2017Don't want to check this manually?
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