Panoramic Rental Corp. recalls Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 w…
- Recall date
- June 4, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2538-2015
- FDA classification
- Class II
- Brand / firm
- Panoramic Rental Corp.
- Sold / distributed
- 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, T…
Why it was recalled
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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