Recall Z-1835-2014 ยท IXY Holder, Radiographic Cassette, Wall-Mounted
Claymount Assembli
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.
| Date | Jun 30, 2014 (initiated Mar 15, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | CDRH approves the CAP subject to the following conditions for Claymount Assemblies BV: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. All forward production of Harmony devices must be properly tested, labeled, and reported when imported into the United States. For further questions please call (630) 271-9729. |
| Quantity | 125 units shipped to United States |
| Distribution | Worldwide Distribution - US including the states of CA, CO, FL, IL, NC, NJ, OH and PA and the countries of Canada, France, Italy, Netherlands, South Africa, Switzerland, Turkey and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.