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Claymount Assembli recalls The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It cont
Recalled July 9, 2014 · FDA recall Z-1835-2014 · Claymount Assembli
Hazard
Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J. · FDA Class II
Units
125 units shipped to United States
Sold at
Worldwide Distribution - US including the states of CA, CO, FL, IL, NC, NJ, OH and PA and the countries of Canada, France, Italy, Netherlands, South Africa, Switzerland, Turkey and United Kingdom.
Description
Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.
Product
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
Manufacturer(s)
Claymount Assembli
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →