On (b)(6) 2015, it was reported to midmark that an x-ray unit (preva intraoral dental x-ray system, serial number (b)(4)) separated from its wall mounting at a user facility in (b)(6).A dealer technician was installing the x-ray unit, and while extending the arm during testing, one of the two fasteners (long socket cap screws) that bolt the control unit to the wall plate fractured, causing the control unit to rotate sideways and the device to fall to the ground.No injuries were reported.Photos of the incident were provided to midmark by the user facility, and the unit was re-installed with new fasteners.The failed fastener was returned to midmark for evaluation.
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