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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE MV Systems

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  Class 2 Device Recall ARTISTE MV Systems see related information
Date Initiated by Firm April 09, 2009
Date Posted September 24, 2009
Recall Status1 Terminated 3 on April 12, 2011
Recall Number Z-1888-2009
Recall Event ID 52723
510(K)Number K072485  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA.

Medical charged-particle radiation therapy system.

Code Information All Product with Part Number 8139789 (RT Therapists are part of the system).
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		 Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 1-925-602-8157.
Quantity in Commerce 53 units
Distribution Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.
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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