Z-1836-2014 Class II Terminated
FDA device recall Z-1836-2014 was initiated by Claymount Assembli on March 15, 2014 and is designated Class II. 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 manufactur… The recall status is terminated (terminated October 18, 2018). Affected quantity: 12 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2014
- Initiation Date
- March 15, 2014
- Termination Date
- October 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
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.
Distribution Pattern
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.
Code Information
*** 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.