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U.S. Department of Health and Human Services

Class 2 Device Recall Mavig Portegra 2

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  Class 2 Device Recall Mavig Portegra 2 see related information
Date Initiated by Firm May 01, 2009
Date Posting Updated June 16, 2009
Recall Status1 Terminated 3 on September 01, 2009
Recall Number Z-1437-2009
Recall Event ID 51947
510(K)Number K930635  
Product Classification Angiographic X-Ray System - Product Code IZI
Product Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7721165 Upper Body radiation shield, fixed.
Code Information 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64166, 64168, 64169, 64170, 64171, 64172, 64177, 64178, 64179, 64180, 64181, 64190, 64194, 64199, 64202, 64212, 64214, 64228, 64231, 64232, 64235, 64236, 64239, 64241, 64243, 64244, 64245, 64246, 64247, 64248, 64253, 64258, and 64259.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Michael Van Ryn
610-219-6300
Manufacturer Reason
for Recall
Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
FDA Determined
Cause 2
Other
Action The recalling firm has decided to inspect all of the installed units for this condition and where necessary replace the missing clip. The recalling firm has issued an Update Instructions AX011/09/S dated 03.09, which provides instructions on how to perform a visual inspection of the Mavig Portegra 2 arm for the presence of the safety clip and the installation instructions on how to properly install the clip if it is missing.
Quantity in Commerce 427 units
Distribution 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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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