Recall Z-1836-2014— Claymount Assembli
Class II · Terminated
Class II FDA medical device recall by Claymount Assembli, initiated 2014-03-15, terminated 2018-10-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Claymount Assembli
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-15
- Terminated
- 2018-10-18
- Firm location
- Dinxperlo, Netherlands
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.