Claymount Harmony2 Grid Cabinet Recalled for Labeling and Insulation Defects
Claymount Assemblies BV is recalling 12 Harmony2 grid cabinets because they lack required labeling information and have non-compliant insulation values.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defects involve labeling errors and insulation non-compliance, which are significant but do not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Claymount Assemblies BV is recalling 12 units of the Harmony2 model of the Harmony Bucky grid cabinet. The device is a component of a radiographic system designed to accept a digital x-ray imaging receptor and stationary grid. The recall is due to two specific defects: the devices are incorrectly labeled, omitting the manufacturer address, date of manufacture, and a statement of compliance with 21 CFR Subchapter J; and the device's insulation values do not comply with IEC 60601-1 in all cases.
The affected devices were distributed worldwide, including in the United States (North Carolina, Ohio, Colorado, California, New Jersey, Illinois, Pennsylvania, and Florida) and internationally to Canada, China, France, Italy, the Netherlands, South Africa, Switzerland, Turkey, and the United Kingdom. Specific serial numbers and part IDs for the 12 affected US devices are listed in the agency's recall record.
The source text does not provide specific instructions for consumers or healthcare facilities on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the defect. Users should refer to the official FDA recall notice for specific remediation steps.
The recalled product
- 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
- Manufacturer
- Claymount Assembli
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- *** 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.
Distribution
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