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Trans-Former
Reina Imaging · Model [T][#]-[Z] · UDI-DI 00860001700121
10
510(k) clearances
32
Adverse events
5
Recalls
32
Facilities
Description
Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility
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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