FDA-Device2020-09-30Class II
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Hazard
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
Sold states
US Nationwide distribution.
Affected count
64 systems US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3005-2020More Siemens Medical Solutions USA, Inc recalls
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