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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Artis MP/Artis dMP and Artis zee Multipurpose

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 Class 2 Device Recall AXIOM Artis MP/Artis dMP and Artis zee Multipurposesee related information
Date Initiated by FirmJuly 13, 2010
Date PostedAugust 16, 2010
Recall Status1 Terminated 3 on July 05, 2012
Recall NumberZ-2233-2010
Recall Event ID 56262
510(K)NumberK010721 K021021 K073290 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductAXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.
Code Information Model numbers 10094139, 5904466, 7555365. Serial numbers 20136, 157435, 20205, 57089, 20334, 20114, 57077, 157458, 20052, 20303, 20343, 20016, 157136, 20208, 20238, 20242, 157436, 57144, 57189, 20322, 20295, 20081, 157448, 20209, 157165, 20254, 20170, 20282, 20076, 157168, 20050, 157213, 20363, 20179, 57035, 157164, 157156, 20202, 20338, 57188, 20348, 20172, 20183, 57073, 20264, 57016, 20325, 20143, 20367, 20258, 57009, 20182, 20175, 157169, 20056, 57004, 20082, 20037, 20053, 157139, 57187, 58702, 20250, 20313, 20100, 20207, 20230, 157146, 20157, 157476, 20249, 57204, 20140, 57111, 20181, 20281, 57171, 20033, 20074, 20165, 57113, 20243, 20178, 57193, 20188, 20339, 57117, 20141, 57041, 57072, 57008, 157414, 20321, 157215, 57198, 57054, 57155, 20097, 20003, 20015, 20233, 20220, 20265, 57098, 57124, 57116, 57045, 157184, 20185, 57156, 57076, 57105, 58701, 20086, 20087, 20217, 157409, 20102, 57012, 57201, 20180, 20294, 157466, 157442, 20129, 157449, 20171, 57024, 57183, 157438, and 157440.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactMeredith A. Adams
610-448-3237
Manufacturer Reason
for Recall		The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion.
FDA Determined
Cause 2		Other
ActionSiemens has issued an "Urgent Field Safety Notice: Customer Safety Information to consignees with Update Instructions AX033/10/S. This letter informed customers of the issue, and provides an Addendum to the User Manual. The Update Instructions describe the process for installation of an additional clamping mechanism provided by Siemens into the existing system, which will be activated if the gearbox is damaged. If activated, the clamping machanism will prevent the C-arm from tilting away, stop regular operation, and alert the operator to check the system and repair the gearbox damage.
Quantity in Commerce131 units
DistributionNationwide distribution: States of AL, AZ, CA, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
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
510(K)s with Product Code = IZI
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