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U.S. Department of Health and Human Services

Class 2 Device Recall Claymount Harmony1 Bucky

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 Class 2 Recall
Claymount Harmony1 Bucky
see related information
Date Posted June 30, 2014
Recall Status1 Open
Recall Number Z-1835-2014
Recall Event ID 67713
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.
Code Information *** 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 , 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; Serial Numbers: WO160580/E-1 , WO166945/E-1 , WO166945/E-2 , WO166946/E-1 , WO166946/E-2 , WO166949/E-1 , WO166949/E-2 , WO166950/E-1 , WO166951/E-1 , WO166952/E-1 , WO166952/E-2 , WO166954/E-1 , WO166954/E-2 , WO166955/E-1 , WO166955/E-2 , WO166957/E-1 , WO166957/E-2 , WO169388/E-1 , WO169388/E-2 , WO172050/E-1 , WO172050/E-2 , WO172051/E-1 , WO172051/E-2 , WO172345/E-1 , WO174072/E-2 , WO175014/E-1 , WO175014/E-2 , WO175015/E-1 , WO175993/E-2 , WO179503/E-1 , WO182220/E-1. 4) Part ID: 17676; Serial Numbers: WO160452/E-1 , WO160453/E-1 , WO165325/E-1 , WO166958/E-1 , WO166958/E-2 , WO166961/E-1 , WO166962/E-1 , WO166962/E-2 , WO166963/E-1 , WO166963/E-2 , WO166964/E-1 , WO166968/E-1 , WO166968/E-1 , WO166968/E-2 , WO166969/E-1 , WO166970/E-1 , WO166970/E-2 , WO167440/E-1 , WO167440/E-2 , WO169398/E 2 , WO169398/E-1 , WO169400/E-1 , WO169400/E-2 , WO169402/E-1 , WO171077/E-1 , WO171077/E-2 , WO171390/E-1 , WO171390/E-2 , WO171391/E-1 , WO171391/E-2 , WO172052/E-1 , WO172052/E-2 , WO172054/E-1 , WO172054/E-2 , WO174099/E-2 , WO175166/E-1 , WO175166/E-2 , WO175169/E-1 , WO175169/E-2. 5) Part ID: 17985; Serial Numbers: WO166912/E-1 , WO166912/E-2 , WO166913/E-1 , WO166913/E-2 , WO169337/E-1 , WO169337/E-2 , WO169338/E-1 , WO172968/E-1 , WO172968/E-2 , WO172969/E-1 , WO172969/E-2 , WO175175/E-1 . 6) Part ID: 18423; Serial Numbers: WO193031/E-1 , WO193031/E-2 , WO193032/E-1 , WO193032/E-2 , WO196488/U-1 , WO196488/U-2 , WO196488/U-3 , WO198927/E-1 , WO198927/E-2 , WO200261/U-1. 7) Part ID: 18424; Serial Numbers: WO193035/E-1 , WO193035/E-2 , WO193036/E-1 , WO193040/E-1 , WO193040/E-2 , WO193041/E-1 , WO196489/U-1 , WO196489/U-2 , WO196489/U-3. 8) Part ID: 18425; Serial Numbers: WO193039/E-1 , WO200259/U-1 , WO200259/U-2 , WO200906/E-1.
Recalling Firm/
Manufacturer
Claymount Assembli
Anholtseweg 44
Dinxperlo
For Additional Information Contact Ms. Alice Packard
630-271-9729
Manufacturer Reason
for Recall
Harmony1 models of the Harmony Bucky is 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.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action CDRH approves the CAP subject to the following conditions for Claymount Assemblies BV: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. All forward production of Harmony devices must be properly tested, labeled, and reported when imported into the United States. For further questions please call (630) 271-9729.
Quantity in Commerce 125 units shipped to United States
Distribution Worldwide Distribution - US including the states of CA, CO, FL, IL, NC, NJ, OH and PA and the countries of Canada, France, Italy, Netherlands, South Africa, Switzerland, Turkey and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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