Device product
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.
Z-2538-2015
Product summary
- Event
- Event 71653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7885
- Official record key
device-enforcement:Z-2538-2015
Official wording
Reason: Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Code information: Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
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.
Derived failure modes
-
Unknown
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.