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U.S. Department of Health and Human Services

Class 2 Device Recall Primeview 3i 2.0

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  Class 2 Device Recall Primeview 3i 2.0 see related information
Date Initiated by Firm October 02, 2007
Date Posted April 30, 2008
Recall Status1 Terminated 3 on December 24, 2008
Recall Number Z-0979-2008
Recall Event ID 46200
510(K)Number K060226  
Product Classification Linear Medical Accelerator - Product Code IYE
Product Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0. Siemens AG, Concord, CA.
Code Information Serial Numbers: 10007, 10021, and 10014
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		 Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference im
FDA Determined
Cause 2		 Software design
Action On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.
Quantity in Commerce 3 units
Distribution Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
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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