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.
This recall has been terminated (originally issued June 21, 2013).
- Recall Initiated
- May 29, 2013
- Posted
- June 21, 2013
- Terminated
- November 26, 2013
- Recall Number
- Z-1562-2013
- Quantity
- 8 units
- Firm Location
- Martinez, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution
Lot / Code Info
All units of the version 4.3, Part No. 08162815
Root Cause
Device Design
Action Taken
Siemens sent an Urgent: Medical Device Correction Customer Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem, what preventive measures can the user take and actions to be taken. Customers were advised to perform the preventive measures provided and inform all affected personnel immediately. The letter states that Siemens is currently working on a new version of the software. Customers are asked to include the Customer Safety Advisory Notice in the System Owner Manual chapter "Safety Advisory Letters". For question call 925-602-8157.