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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
Related recalls
Same manufacturer · Claymount Assembli
See all →- ModerateClaymount Harmony2 Grid Cabinet Recalled for Labeling and Insulation Defects
FDA (Devices) · 2014-07-09
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateClaymount Harmony2 Grid Cabinet Recalled for Labeling and Insulation Defects
FDA (Devices) · 2014-07-09
- HighMedical imaging device missing required radiation safety labels
FDA (Devices) · 2021-12-01
- HighSiemens APTIO Rack Output Module Recall for Missing Warning Label
FDA (Devices) · 2018-10-31
- HighSiemens APTIO 15000 Refrigerated Storage Module Recall for Missing Warning Label
FDA (Devices) · 2018-10-31
- HighSiemens APTIO 9000 Refrigerated Storage Module Recall for Missing Warning Label
FDA (Devices) · 2018-10-31
- ModerateMedical Device MRI Cooling Cabinet Warning Label Missing High-Voltage Symbol
FDA (Devices) · 2024-01-31