Recall Z-1836-2014 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. It is intended to be used in general radiographic applications as a component of a radiographic
| Date | Jun 30, 2014 (initiated Mar 15, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | MEDICAL DEVICE RECALL letters dated March 15, 2014 were sent to all direct accounts. The letters includes instructions to: 1) complete and return the Acknowledgement and Receipt Form accompanying the letter; 2) replace the Harmony2 Bucky(s) with new Harmony3 Bucky(s) that the direct account will be receiving in the near future; 3) if the direct account is a distributor and/or installer and it elects to have their customer(s) perform the replacement, the customer(s) should be provided with a copy of the letter, the replacement Harmony3 Bucky(s), and the replacement notification card, or the dir |
| Quantity | 12 devices |
| Distribution | Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, 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.