FDAFDA · Food and drugs·Recall number Z-2538-2015
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.
Published September 9, 2015 · Recall initiated: June 4, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Panoramic Rental Corp.
- Distributor
- 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.
- Lot
- Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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