ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. Siemens Healthcare, Concord, CA. The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
This recall has been terminated (originally issued May 12, 2011).
- Recall Initiated
- March 24, 2011
- Posted
- May 12, 2011
- Terminated
- February 13, 2012
- Recall Number
- Z-2190-2011
- Quantity
- 228 active devices
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
Distribution
Worldwide Distribution
Lot / Code Info
ARTIST Systems include: Therapist Express Basic Part number 08515289; Therapist Express Assist Part number 08515297; syngo RT Therapist Assist Part number 08162807; syngo RT Therapist Part number 08162815; and sysno RT Therapist connect/MPSAOQ OIS Part number 08168754.
Root Cause
Pending
Action Taken
Distribution of the Urgent: Medical Device Correction Customer Advisory Notice began on March 24, 2011 via certified mail or by the Siemens Customer Service Group. The letter identified the issue and when it occurs. Users were asked to verify the isocenter position of the reference image in the Portal Review application before using a reference image imported from the treatment planning system. Siemens is currently working on a solution and will notify customers as soon as the update is available. The letter should be included with the Owner Manual of the system in the chapter for "Safety Advisory Letters" until an update is provided.