The Claymount Harmony is a grid cabinet designed to accept a digital… — Class II medical device recall Z-1835-2014
Terminated recall by Claymount Assembli, reported 2014-07-09, distributed in CA, CO, FL, IL, NC, NJ, OH, PA. Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer a
| Recall number | Z-1835-2014 |
|---|---|
| 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, FR, GB, IT, NL, TR, ZA |
| Quantity | 125 units |
| Reason classes | labeling |
| Serial numbers | WO160452/E-1, WO160453/E-1, WO160580/E-1, WO165307/E-1, WO165308/E-1, WO165325/E-1, WO166912/E-1, WO166912/E-2, WO166913/E-1, WO166913/E-2, WO166945/E-1, WO166945/E-2, WO166946/E-1, WO166946/E-2, WO166949/E-1, WO166949/E-2, WO166950/E-1, WO166951/E-1, WO166952/E-1, WO166952/E-2, WO166954/E-1, WO166954/E-2, WO166955/E-1, WO166955/E-2, WO166957/E-1 and 98 more |
| Model numbers | 17007, 17009, 17675, 17676, 17985, 18423, 18424, 18425 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1835-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.