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U.S. Department of Health and Human Services

Class 2 Device Recall Claymount Harmony2 Bucky

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  Class 2 Device Recall Claymount Harmony2 Bucky see related information
Date Initiated by Firm March 15, 2014
Date Posted June 30, 2014
Recall Status1 Open3, Classified
Recall Number Z-1836-2014
Recall Event ID 67715
Product Classification Holder, radiographic cassette, wall-mounted - Product Code IXY
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.
Code Information *** 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.
Recalling Firm/
Claymount Assembli
Anholtseweg 44
Dinxperlo Netherlands
For Additional Information Contact Ms. Alice Packard
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.