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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 Recall
Siemens Artis zee Ceiling Systems
see related information
Date Posted February 24, 2014
Recall Status1 Terminated on March 09, 2015
Recall Number Z-1080-2014
Recall Event ID 67175
Premarket Notification
510(K) Number
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/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
During the lifetime of Artis zee Ceiling systems serial numbers from 146352 to 147617, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
FDA Determined
Cause 2
DESIGN: 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 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.