Recalls for Holder, Radiographic Cassette, Wall-mounted

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.

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.

Unintentional U-Arm movement

The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.

The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.