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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 Recall
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose
see related information
Date Posted August 16, 2010
Recall Status1 Terminated on July 05, 2012
Recall Number Z-2233-2010
Recall Event ID 56262
Premarket Notification
510(K) Numbers
K010721  K021021  K073290 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product AXIOM 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, Pennsylvania 19355
Consumer Instructions No consumer action necessary
For Additional Information Contact Meredith 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/UNDETERMINED: Pending
Action Siemens 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 Commerce 131 units
Distribution Nationwide 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 Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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