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

FDA device recall Z-1835-2014 · posted 2014-06-30 · Terminated

Recall details

Recalling firm

Claymount Assembli

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IXY

Quantity affected

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.

Date initiated

2014-03-15

Date posted

2014-06-30

Date terminated

2018-10-18

Location

Dinxperlo, Netherlands