openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
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.
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.
Code information
Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only: 10010 10046 10586 No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S.
