Skip to content
Recall Observatory FDA recall evidence

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

June 04, 2015

Class II

Product summary

Firm
Panoramic Rental Corp.
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

    reason.no_named_rule · v1.0.0

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