Z-2538-2015 Class II Terminated

Recalled by Panoramic Rental Corp. — Fort Wayne, IN

Recall Details

Product Type
Devices
Report Date
September 9, 2015
Initiation Date
June 4, 2015
Termination Date
May 30, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7885

Product Description

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.

Reason for Recall

Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.

Distribution Pattern

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.

Code Information

Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003