Claymount Assembli: Medical Device Recall in 2014 - (Recall #: Z-1836-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 15, 2014

Date Posted: July 9, 2014

Recall Number: Z-1836-2014

Event ID: 67715

Reason for Recall:

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 of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.

Status: Terminated

Product Quantity: 12 devices

Code Information:

*** US Devices Only *** 1) Part ID: 17360; Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1. 2) Part ID: 17361; Serial Numbers: WO186723/E-1. 3) Part ID: 17362; Serial Numbers: WO186724/E-1 , WO196360/E-1 , WO198545/E-2. 4) Part ID: 18476; Serial Numbers: WO196188/E-1 , WO196188/E-2 , WO196189/E-2. 5) Part ID: 18477; Serial Numbers: WO198547/E-1. 6) Part ID: 18479; Serial Numbers: WO198552/E-1.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated