The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It…

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.

Lot codes and dates

• *** US Devices Only *** 1)
• Part ID17007
• Serial Numbers
  • WO171240/E-1
  • WO171240/E-2. 2)
• Part ID17009
• 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 ID17675
• 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 ID17676
• 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 ID17985
• 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 ID18423
• 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 ID18424
• 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 ID18425
• Serial Numbers
  • WO193039/E-1
  • WO200259/U-1
  • WO200259/U-2
  • WO200906/E-1

Amount recalled

125 units shipped to United States

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

• The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging…

Where it was sold

• CA
• CO
• FL
• IL
• NC
• NJ
• OH
• PA

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.