Date Initiated by Firm |
March 28, 2017 |
Date Posted |
March 30, 2017 |
Recall Status1 |
Terminated 3 on August 07, 2017 |
Recall Number |
Z-1824-2017 |
Recall Event ID |
76869 |
510(K)Number |
K073290
|
Product Classification |
System, x-ray, angiographic - Product Code IZI
|
Product |
Artis zee, Angiographic x-ray system |
Code Information |
Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
Meredith Adams 610-219-4834
|
Manufacturer Reason for Recall |
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens mailed a Customer Safety Advisory Notice (CSAN) AX017/17/S to affected customers on 03/28/2017 to inform them of the corrective action that will be performed to prevent a possible hazard to persons and equipment. The notice also explained the underlying issue, the impact on system operation, potential risk to patients and actions they are taking to correct the issue. |
Quantity in Commerce |
3 units distributed in U.S. |
Distribution |
Distributed to: VA, CA, WI |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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