FDA Device recall Z-1836-2014
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid by Claymount Assembli, citing 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, t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1836-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-15 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Claymount Assembli |
| Distribution | CA, CO, FL, IL, NC, NJ, OH, PA |
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
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.
Identifiers
| code_info | *** US Devices Only *** 1) Part ID: 17360; Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1. 2) Par…*** 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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2014%22
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