Device product
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Z-1562-2013
Product summary
- Event
- Event 65435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-1562-2013
Official wording
Reason: The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
Code information: All units of the version 4.3, Part No. 08162815
Distribution pattern: Worldwide distribution
Derived failure modes
-
Unknown
The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.