FDA-Device2014-07-09Class II
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.
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.
Sold states
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.
Affected count
125 units shipped to United States
Manufactured in
Anholtseweg 44, Dinxperlo, Netherlands
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2014Don't want to check this manually?
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