FDA Device recall Z-2180-2014
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software…
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2180-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-17 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | NY, UT, WI |
Product
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.
Reason
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.
Identifiers
| code_info | Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2180-2014%22
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