Z-0016-2017 Class II Terminated

Recalled by Panoramic Rental Corp. — Fort Wayne, IN

Recall Details

Product Type
Devices
Report Date
October 12, 2016
Initiation Date
August 19, 2016
Termination Date
January 11, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,340

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution including Puerto Rico

Code Information

Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340