Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator syste
FDA device recall Z-1013-2015 · posted 2015-01-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3
- Distribution
- UT, WI, NY
- Date initiated
- 2015-01-02
- Date posted
- 2015-01-26
- Date terminated
- 2015-09-10
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 (K142434) | Siemens Medical Solutions USA, Inc. | 2014-11-21 |