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U.S. Department of Health and Human Services

Class 2 Device Recall camera imaging system

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  Class 2 Device Recall camera imaging system see related information
Date Initiated by Firm November 04, 2010
Date Posted June 23, 2011
Recall Status1 Terminated 3 on November 14, 2011
Recall Number Z-2635-2011
Recall Event ID 58813
510(K)Number K903139  
Product Classification Accelerator, linear, medical - Product Code IYE
Product BEAMVIEW IT, camera imaging system, Part Number: 5410389 & 5852301;
Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS
Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS
Henkestrasse, Erlangen, GERMANY

The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information All units of these part numbers: 5410389 & 5852301 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc - Radiation Oncology
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar
925-246-8407
Manufacturer Reason
for Recall		 The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
FDA Determined
Cause 2		 Other
Action The firm, SIEMENS, sent a "Customer Information" letter to its customers on November 4, 2010. The letter describes the product, problem and actions to be taken. The customers were instructed to include this letter in their BEAMVIEW TI System Owner Manual chapter "Safety Advisory Letters" where it should remain. Siemens has developed an updated kit to install an additional grounding cable on the camera's central control unit to eliminate the problem. The updated kit was delivered with the Customer Information letter. If you have any questions, contact the Service Manager- Regulatory Affairs at 925-246-8407.
Distribution Worldwide 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 LABORATORIES, INC.
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