Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
FDA Recall Z-2075-2014 · Posted 2014-07-17
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-05-15
Date Terminated2014-12-15
Product Quantity7
Reason for Recall
An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI
Firm Action
Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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