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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dTA

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  Class 2 Device Recall Axiom Artis dTA see related information
Date Initiated by Firm September 02, 2008
Date Posted November 25, 2008
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0122-2009
Recall Event ID 49584
510(K)Number K010721  K021021  
Product Classification Angiography X-Ray - Product Code IZI
Product Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605.
Code Information Model number 7008605. Serial numbers: 55001, 55003, 55019, 55021, 55036, 55037, 55043, 55048, 55138, 55162, 55166, 55181, 55242, 55255, 55264, 55266, 55278, 55280, 55288, 55298, 55323, 55333, 55341, 55347, 55349, 55350, 55351, 55358, 55361, 55368, 55377, 55378, 55386, 55396, 55397, 55399, 55402, 55407, 55408, 55409, 55410, 55411, 55412, 55414, 55415, 55416, 55417, 55418, 55419, 55420, 55421, 55422, 55423, 55424, 55425, 55426, 55427, 55428, 55429, 55430, 55431, 55432, 55433, 55434, 55435, 55436, 55437, 55438, 55439, 55440, 55441, 55442, 55443, 55444, 55445, 55446, 55447, 55448, 55449, 55450, 55452, 55453, 55454, 55455, 55456, 55457, 55458, 55459, 55460, 55461, 55462, 55463, 55464, 55465, 55466, 55467, 55468, 55470, 55471, 55472, 55473, 55474, 55476, 55477, 55478, 55479, 55480, 55481, 55482, 55483, 55484, 55485, 55486, 55487, 55488, 55489, 55490, 55492, 55493, 55494, 55495, 55496, 55497, 55498, 55499, 55500, 55501, 55502, 55503, 55504, 55506, and 55507.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall		 Incorrect contour finding: Image may be calibrated to the wrong size catheter.
FDA Determined
Cause 2		 Software design
Action Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
Quantity in Commerce 133 units
Distribution 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 = IZI and Original Applicant = SIEMENS MEDICAL CORP.
510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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