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        "reason": "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations."
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        "reason": "Due to software issue,  Radiation Therapy Planning system may provide incorrect dataset calculations when performing the  \"Stopping Power Ratio\" (SPR) ,"
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        "reason": "When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen."
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        "reason": "An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit."
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        "reason": "An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit."
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