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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm April 04, 2012
Date Posted May 08, 2012
Recall Status1 Terminated 3 on September 17, 2012
Recall Number Z-1494-2012
Recall Event ID 61578
510(K)Number K060226  K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system;
Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200;


ARTISTE/ONCOR/PRIMUS systems are manufactured by:
SIEMENS AG, MEDICAL SOLUTIONS,
Roentgenstrasse 19-21,
Kemnath, GERMANY 95478

Product Usage:
Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information All units of these models.
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		 The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury.
FDA Determined
Cause 2		 Process control
Action Siemens sent an Update Instruction containing the Customer Information letters beginning April 4, 2012 delivered by Siemens customer Service Group or by certified mail to all affected customers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter instructs customer to include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.
Quantity in Commerce 73 units
Distribution Worldwide Distribution - USA Nationwide
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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