Panoramic Rental Corp. recalls Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take pan…

Recall date

August 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0016-2017

FDA classification

Class II

Brand / firm

Panoramic Rental Corp.

Sold / distributed

US Nationwide Distribution including Puerto Rico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.