Claymount Harmony Grid Cabinets Recalled for Missing Label Information
Claymount Assembli is recalling Harmony grid cabinets because their labels lack the manufacturer address, date of manufacture, and required compliance statements.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for documentation and labeling issues (missing address, date, and compliance statement) with no reported injuries or functional safety hazards, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Claymount Assembli is recalling specific models of the Harmony grid cabinet, a medical device designed to accept digital x-ray imaging receptors and stationary grids. The recall is due to labeling defects where the product labels do not list the manufacturer's address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.
The affected units were distributed to the United States and several international countries, including Canada, France, Italy, the Netherlands, South Africa, Switzerland, Turkey, and the United Kingdom. Specific serial numbers and part IDs for the affected units are listed in the official recall documentation.
Healthcare facilities and users should identify if they possess the affected serial numbers and contact the recalling firm for instructions on how to proceed with the recall.
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
- Hazard
- Affected units
- 125
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 (20)
- *** US Devices Only *** 1) Part ID: 17007
- Serial Numbers: WO171240/E-1
- WO171240/E-2. 2) Part ID: 17009
- Serial Numbers: WO165307/E-1
- WO165308/E-1
- WO170263/E-1
- WO172341/E-1
- WO172760/E-1
- WO172760/E-2
- WO174533/E-2
- WO174980/E-2
- WO175009/E-1
- WO175010/E-2
- WO175011/E-1
- WO175011/E-2
- WO175013/E-1
- WO175013/E-2
- WO177682/E-1
- WO187248/E-1
- WO191933/E-2. 3) Part ID: 17675
Distribution
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