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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee Angiographic xray system

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 Class 2 Device Recall Artis zee Angiographic xray systemsee related information
Date Initiated by FirmMarch 28, 2017
Date PostedMarch 30, 2017
Recall Status1 Terminated 3 on August 07, 2017
Recall NumberZ-1824-2017
Recall Event ID 76869
510(K)NumberK073290 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductArtis zee, Angiographic x-ray system
Code Information Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMeredith 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
ActionSiemens 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 Commerce3 units distributed in U.S.
DistributionDistributed to: VA, CA, WI
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
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