On (b)(6) 2015 it was reported to midmark by a dealer representative that a x-ray unit (preva intraoral dental x-ray system, serial number (b)(4)) separated from its wall striking the patient present in the room at the time, in the head and rendering the person unconscious.The patient was taken to emergency room and was released the next day without additional issues reported.No other patient information has been disclosed.The unit mounting was visually inspected at the user facility and photographs were provided to midmark.Dealer representative reported that the upper lag bolt of the unit came out of the wood it was secused to and confirmed that the cause of this incident was installation error.Preva installation manual ((b)(4)) provided with the unit, gave clear, detailed instructions for unit installation on a dual stud wall.The unit has since been reinstalled by a dealer technician.Midmark also confirmed dealer's investigation and cause summary.
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