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. It is intended to be used in general radiographic applications as a component of a radiographic system.

Recall Insight

This FDA Devices action (record #Z-1836-2014) was formally reported on July 9, 2014, with the manufacturer initiating the action on March 15, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Claymount Assembli is listed as the recalling firm, operating out of Dinxperlo. Federal records list the affected scope as 12 devices.

The documented reason for this recall is: Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement o… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, France, Italy, Netherlands, South Africa, Switzerland, Turkey, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.