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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM

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  Class 2 Device Recall AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM see related information
Date Initiated by Firm August 25, 2008
Date Posted December 09, 2008
Recall Status1 Terminated 3 on January 26, 2010
Recall Number Z-0314-2009
Recall Event ID 49569
510(K)Number K052202  
Product Classification Angiographic x-ray system - Product Code IZI
Product AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors.

¿AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Code Information Model number 7555373. Serial numbers: 50176 and 51707
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall		 System may switch to emergency fluoroscopy mode.
FDA Determined
Cause 2		 Software design
Action A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.
Quantity in Commerce 2 units
Distribution Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.
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 SOLUTIONS USA, INC.
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