FDAFDA · Food and drugs·Recall number Z-1835-2014
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.
Published July 9, 2014 · Recall initiated: March 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Claymount Assembli
- Distributor
- 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.
- Lot
- *** 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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