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-1836-2014 · posted 2014-06-30 · Terminated

Recall details

Recalling firm

Claymount Assembli

Reason for recall

Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are 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, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.

Action taken

MEDICAL DEVICE RECALL letters dated March 15, 2014 were sent to all direct accounts. The letters includes instructions to: 1) complete and return the Acknowledgement and Receipt Form accompanying the letter; 2) replace the Harmony2 Bucky(s) with new Harmony3 Bucky(s) that the direct account will be receiving in the near future; 3) if the direct account is a distributor and/or installer and it elects to have their customer(s) perform the replacement, the customer(s) should be provided with a copy of the letter, the replacement Harmony3 Bucky(s), and the replacement notification card, or the direct account can provide the names and addresses of their customers in which case Claymount will contact the customers directly; and, 4) once each unit is replaced, the replacement completion notification card should be mailed or faxed to the Claymount USA office and the Harmony2 Bucky(s) should be returned to "Claymount Americas Corp., ATTN: Alice Packard, 2545 Curtiss St., Downers Grove, IL 60515-4059" or faxed to 630-271-9995. For questions customers were instructed to call the following numbers: USA (630) 271-9729 EUR +31 315 659 150

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IXY

Quantity affected

12 devices

Distribution

Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, 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