Z-1835-2014Class II

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

Name: Z-1835-2014 The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary...
Creator: Claymount Assembli
Published: 2014-03-15
License: https://open.fda.gov/license/

Varex Imaging Nederland B.V. / initiated 2014-03-15 / Terminated / root cause: labeling and UDI

FDA source

Claymount Assembli began a recall of 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... on 2014-03-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1835-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-15
Posted: 2014-06-30
Terminated: 2018-10-18
Recalling firm: Varex Imaging Nederland B.V.
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.
Product code: IXY Holder, Radiographic Cassette, Wall-Mounted
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.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: *** 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1835-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1835-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-30

Product code IXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)