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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 Recall
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus
see related information
Date Posted July 17, 2013
Recall Status1 Open
Recall Number Z-1750-2013
Recall Event ID 65620
Premarket Notification
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/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
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
DESIGN: 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 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 SOLUTIONS USA, INC.
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