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U.S. Department of Health and Human Services

Class 2 Device Recall Linear Accelerator

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  Class 2 Device Recall Linear Accelerator see related information
Date Initiated by Firm June 03, 2011
Date Posted August 11, 2011
Recall Status1 Terminated 3 on February 17, 2012
Recall Number Z-3003-2011
Recall Event ID 59122
510(K)Number K072485  K060226  K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARTISTE Linear Accelerator with RT Therapist v4.1 system.
Siemens Medical Solutions, Kemnath, Germany.
Distributed by Siemens Medical Solutions, Concord, CA 94520.

Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
Code Information Therapist Express Basic, Part Number 08151289; Therapist Express Assist, Part Number 08151297; syngo RT Therapist Assist, Part Number 08162807; syngo RT Therapist, Part Number 08162815; syngo RT Therapist Connect/MOSIAQ 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		 A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.
FDA Determined
Cause 2		 Software design
Action Siemens sent an "Urgent: Medical Device Correction/ Customer Safety Advisory Notice" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should remain.
Quantity in Commerce 223 active devices
Distribution Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and United Kingdom.
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 = SIEMENS MEDICAL SOLUTIONS USA, INC.
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