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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis Zee Family

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  Class 2 Device Recall Siemens Artis Zee Family see related information
Date Initiated by Firm February 07, 2014
Date Posted March 31, 2014
Recall Status1 Terminated 3 on March 16, 2015
Recall Number Z-1309-2014
Recall Event ID 67558
510(K)Number K073290  
Product Classification Angiographic x-ray system - Product Code IZI
Product Artis Zee Angiographic x-ray systems.
Code Information Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
FDA Determined
Cause 2
Device Design
Action A recall notification letter dated February 7, 2014, was sent to End Users.
Quantity in Commerce 9
Distribution MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
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.