Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-2180-2014 · Posted 2014-08-10
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-06-17
Date Terminated2014-12-15
Product Quantity56
Reason for Recall
Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.
Firm Action
In June, 2014, an urgent medical device correction field safety notice of improvement was sent to end users informing them of the product, problem, and action to be taken to avoid the potential safety issue.
Root Cause
Software design
Distribution Pattern
UT, WI, NY
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.