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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE / RT Therapist v4.1 system

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  Class 2 Device Recall ARTISTE / RT Therapist v4.1 system see related information
Date Initiated by Firm March 24, 2011
Date Posted May 12, 2011
Recall Status1 Terminated 3 on February 13, 2012
Recall Number Z-2190-2011
Recall Event ID 58517
510(K)Number K060226  K072486  K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer 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.
FDA Determined
Cause 2		 Pending
Action 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.
Quantity in Commerce 228 active devices
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = HEMCON MEDICAL TECHNOLOGIES, INC.
510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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