Recall Z-1835-2014— 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.. Reason: 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..
- 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.