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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis zee Ceiling Systems

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  Class 2 Device Recall Siemens Artis zee Ceiling Systems see related information
Date Initiated by Firm December 16, 2013
Date Posted February 24, 2014
Recall Status1 Terminated 3 on March 09, 2015
Recall Number Z-1080-2014
Recall Event ID 67175
510(K)Number K073290  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Siemens Artis zee Ceiling Systems.

Angiographic x-ray system.
Code Information Artis zee Ceiling systems serial numbers from 146352 to 147617
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
FDA Determined
Cause 2		 Device Design
Action In December 2013, a recall notification letter was sent to Users.
Quantity in Commerce 284
Distribution Nationwide Distribution.
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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