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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