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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 Open
Recall Number Z-1080-2014
Recall Event ID 67175
Premarket Notification
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, Pennsylvania 19355
For Additional Information Contact Customer Support
610-219-6300
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.
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