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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Axiom Artis

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 Class 2 Recall
Siemens Axiom Artis
see related information
Date Posted August 28, 2013
Recall Status1 Open
Recall Number Z-2108-2013
Recall Event ID 65793
Premarket Notification
510(K) Numbers
K010721  K021021 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Code Information Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Siemens Customer Service
610-219-6300
Manufacturer Reason
for Recall
The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300.
Quantity in Commerce 178
Distribution US Distribution including the states of PA, NJ, DC, VA, MD and DE.
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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