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Varex Imaging
Varex Imaging Nederland B.V. · Model 19407-08 · UDI-DI 08718755001648
IXY
Prescription
10
510(k) clearances
32
Adverse events
5
Recalls
32
Facilities
Description
The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-series.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-08 | Konica Minolta Healthcare, Americas, Inc. | Unintentional U-Arm movement |
| 2015-12-03 | Del Medical, Inc. | The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. |
| 2015-12-03 | Del Medical, Inc. | The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. |
| 2014-03-15 | Claymount Assembli | 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 |
| 2014-03-15 | Claymount Assembli | 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, th |
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