Reported Sep 30, 2020 · Terminated
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- SoftwareSyngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK
- Intended Useused as an advanced
- application on a SOM10 scanner SMN10496180
- Lot codes and dates
- Serial Numbers
64 of 64 codes
100418100419100420100421100641100642100643100644100645100704100713100735100811100812100813100814101724102013102031102108102305102369130125130140130331130335130628130751130848130874131012131169131247131284131325131336131360131503131578131589131801131966132011132061132102132108132136132231132595132729222224222411222417222475222491222539222563222601222638222686
- Serial Numbers
- Amount recalled
- 64 systems US
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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