Protect-A-Grid

Reina Imaging · Model P[2][X]DR[NG][Y] · UDI-DI 00860001700183

510(k) clearances

Adverse events

Recalls

Facilities

Description

The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. "

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	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
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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.