Class 2 Device Recall Claymount Harmony1 Bucky

• Date Initiated by Firm: March 15, 2014
• Date Posted: June 30, 2014
• Recall Status: Terminated on October 18, 2018
• 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.
• FEI Number: 3006383214
• Recalling Firm/ Manufacturer: Claymount Assembli; Anholtseweg 44; Dinxperlo Netherlands
• 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: 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.