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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems

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  Class 2 Device Recall ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems see related information
Date Initiated by Firm June 03, 2011
Date Posted August 10, 2011
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-2977-2011
Recall Event ID 59107
510(K)Number K080906  K009088  K009082  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems.
Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany.

Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information The ARTISTE RT Therapist v4.2 and Oncologist v4.2 is used on the following: syngo RT Oncologist Part # 10652131; Therapist Express Basic, Part # 08151289; syngo RT Therapist, Part # 08162815; syngo RT Therapist Connect / MOSAIQ OSI, part # 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 rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.
FDA Determined
Cause 2		 Software design
Action Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides preventive measure instructions for customers to use until an update for the system is available.
Quantity in Commerce 121 devices
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, 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 = CDB CORPORATION
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