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.
Reported: June 26, 2013 Initiated: May 29, 2013 #Z-1562-2013
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 8 units
- Distribution
- Worldwide distribution
- Location
- Martinez, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 8 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2013. Severity: Moderate. Recall number: Z-1562-2013.
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