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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis MP

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 Class 2 Device Recall Axiom Artis MPsee related information
Date Initiated by FirmOctober 26, 2009
Date PostedDecember 03, 2009
Recall Status1 Terminated 3 on January 26, 2010
Recall NumberZ-0483-2010
Recall Event ID 53844
510(K)NumberK010721 
Product Classification Angiographic x-ray system - Product Code IZI
ProductAxiom Artis MP, Model number 5904466 angiographic x-ray systems
Code Information Serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20052, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactMeredith Adams
610-219-6300
Manufacturer Reason
for Recall		c-arm may tilt
FDA Determined
Cause 2		Other
ActionThe firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.
Quantity in Commerce70 units
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
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