FDA Device recall Z-1013-2015
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-…
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-… by Siemens Medical Solutions Usa, citing combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1013-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-02 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | NY, UT, WI |
Product
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Reason
Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.
Identifiers
| code_info | model # 08162815, serial #s 10010, 10046, 10586 |
|---|
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-1013-2015%22
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