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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus

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  Class 2 Device Recall Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus see related information
Date Initiated by Firm January 31, 2013
Date Posted July 17, 2013
Recall Status1 Terminated 3 on November 12, 2014
Recall Number Z-1750-2013
Recall Event ID 65620
510(K)Number K090745  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus

Product Usage:
Angiographic x-ray system
Code Information Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
FDA Determined
Cause 2
Device Design
Action Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013.
Quantity in Commerce 23
Distribution United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
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.