Claymount Assembli: 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.

Recall number

Z-1836-2014

Recalling firm

Claymount Assembli

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 in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.

Status

Terminated

Initiated

2014-03-15

Posted

2014-06-30

Terminated

2018-10-18

Reason

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.

Root cause

Radiation Control for Health and Safety Act

Action

MEDICAL DEVICE RECALL letters dated March 15, 2014 were sent to all direct accounts. The letters includes instructions to: 1) complete and return the Acknowledgement and Receipt Form accompanying the letter; 2) replace the Harmony2 Bucky(s) with new Harmony3 Bucky(s) that the direct account will be receiving in the near future; 3) if the direct account is a distributor and/or installer and it elects to have their customer(s) perform the replacement, the customer(s) should be provided with a copy of the letter, the replacement Harmony3 Bucky(s), and the replacement notification card, or the direct account can provide the names and addresses of their customers in which case Claymount will contact the customers directly; and, 4) once each unit is replaced, the replacement completion notification card should be mailed or faxed to the Claymount USA office and the Harmony2 Bucky(s) should be returned to "Claymount Americas Corp., ATTN: Alice Packard, 2545 Curtiss St., Downers Grove, IL 60515-4059" or faxed to 630-271-9995. For questions customers were instructed to call the following numbers: USA (630) 271-9729 EUR +31 315 659 150

Quantity

12 devices

Distribution

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.

Lot, serial or model codes

*** 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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

IXY

Firm FEI

3006383214

Firm city

Dinxperlo

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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