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U.S. Department of Health and Human Services

Class 2 Device Recall Artiste MV Digital Linear Accelerator

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  Class 2 Device Recall Artiste MV Digital Linear Accelerator see related information
Date Initiated by Firm October 23, 2008
Date Posted January 14, 2009
Recall Status1 Terminated 3 on December 09, 2010
Recall Number Z-0857-2009
Recall Event ID 50477
510(K)Number K072485  
Product Classification Medical Linear Accelerator - Product Code IYE
Product Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System.

Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
Code Information Part # 8139789, with Syngo RT Therapist version 4.1 build 67
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
925-246-8407
Manufacturer Reason
for Recall		 Under certain conditions, the flat panel may move unexpectedly and collide with the patient.
FDA Determined
Cause 2		 Labeling design
Action The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediately. The firm is tracking responses via return cards and completion protocol.
Quantity in Commerce 31 consignees have the configuration noted above.
Distribution Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada.
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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