Z-2538-2015 Class II Terminated
FDA device recall Z-2538-2015 was initiated by Panoramic Rental Corp. on June 4, 2015 and is designated Class II. Reason for recall: Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. The recall status is terminated (terminated May 30, 2017). Affected quantity: 7885.
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