| Class 2 Device Recall Siemens Artis Zee Family |  |
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/ 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 | 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
|
|
|
|