Reported Jul 9, 2014 · Terminated
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It…
Claymount Assembli
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Claymount Assembli · Anholtseweg 44 · Dinxperlo · N/A
Is this the product you have?
- 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.
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 17360 2 Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1. 2) Part ID: 17361 3 Serial Numbers: WO186723/E-1. 3) Part ID: 17362 4 Serial Numbers: WO186724/E-1 , WO196360/E-1 , WO198545/E-2. 4) Part ID: 18476 5 Serial Numbers: WO196188/E-1 , WO196188/E-2 , WO196189/E-2. 5) Part ID: 18477 6 Serial Numbers: WO198547/E-1. 6) Part ID: 18479 7 Serial Numbers: WO198552/E-1. - Amount recalled
- 12 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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