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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC)

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  Class 2 Device Recall Siemens 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) see related information
Date Initiated by Firm April 01, 2014
Date Posted May 21, 2014
Recall Status1 Terminated 3 on December 11, 2014
Recall Number Z-1645-2014
Recall Event ID 67957
510(K)Number K072485  K031764  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC)

To deliver X-ray radiation for therapeutic treatment of cancer.
Code Information material #8139789 , 5857912, 7360717, 1940035, 8139789, 4504200, 5863472, serial # 5377, 5087, 70-4262, 5170, 5282  5506  3287  5527  5517  70-4378  3695  5364  5060  5205  5688  5743  70-4283  5190  5157  5343  5844  5148  5391  5300  70-4296  5474  70-4363  70-4368  3793  3817  5833  5899  5207  5355  70-4159  3524  5281  5894  5374  5558  3631  3835  5784  2765  5367  70-4354  70-4356  5540  5488  5590  5657  5350  5821  3413  5222  5843  5179  70-4129  5851  5098  5153  5700  5410  3825  5865  5118  5548  3769  5861  70-4188  5748  70-4317  5737  5830  5385  5656  3778  5088  5665  5823  5353  5630  5480  5096  5572  3873  5417  4059  5500  5388  70-4379  5226  5601  5640  5033  5177  5707  5398  4091  5532  70-4306  70-4161  5424  5755  5326  5145  5699  4079  4082  70-4077  70-4113  5525  5419  3975  5093  5481  5396  3089  5095  5154 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Medical Device Correction, Field Safety Notice of Improvement to End users in March 2014, informing them that a Siemens representative would install a software update. By installation of this software update the issues were solved by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced. Please include this Field Safety Notice in your Digital Linear Accelerator System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority has been informed of this update. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. Further questions please call (610) 219-6300.
Quantity in Commerce 120
Distribution USA ( nationwide) Distribution.
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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