The Claymount Harmony is a grid cabinet designed to accept a digital… — Class II medical device recall Z-1836-2014
Terminated recall by Claymount Assembli, reported 2014-07-09, distributed in CA, CO, FL, IL, NC, NJ, OH, PA. Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectl
| Recall number | Z-1836-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Claymount Assembli, Dinxperlo, Netherlands |
| Recall initiated | 2014-03-15 |
| Classified | 2014-06-30 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2018-10-18 |
| Distributed | CA, CO, FL, IL, NC, NJ, OH, PA |
| Countries outside the US | CA, CH, CN, FR, GB, IT, NL, TR, ZA |
| Quantity | 12 devices |
| Reason classes | labeling |
| Serial numbers | WO186722/E-1, WO186723/E-1, WO186724/E-1, WO196188/E-1, WO196188/E-2, WO196189/E-2, WO196360/E-1, WO196470/E-1, WO198534/E-1, WO198545/E-2, WO198547/E-1, WO198552/E-1 |
| Model numbers | 17360, 17361, 17362, 18476, 18477, 18479 |
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. It is intended to be used in general radiographic applications as a component of a radiographic system.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.