Medical device recalls Moderate risk

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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