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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS zee and zeego

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 Class 2 Recall
ARTIS zee and zeego
see related information
Date Posted July 22, 2013
Recall Status1 Open
Recall Number Z-1782-2013
Recall Event ID 65651
Premarket Notification
510(K) Numbers
K073290  K090745 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Code Information Model numbers: 10094137, 10094139, 10094141, 10280959
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Siemens Customer Service Organization
888-826-9702
Manufacturer Reason
for Recall
Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui
FDA Determined
Cause 2
DESIGN: Software Design Change
Action Siemens sent a Customer Safety Advisory Notice dated June 26, 2013, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were strongly recommend to carefully evaluate one of the following options before running 3D rotational acquisition programs that include real-time subtraction until a patch is installed on their system: 1) position the monitor in a way such that contrast advancement can be monitored during the fill phase on the live monitor in the control room. 2) For applications not requiring actions based on the contrast flow during the fill phase, the contrast may not need to be monitored during the fill phase. Although the monitor is not showing the expected subtraction, the acquisition is working correctly. There is no need to interrupt, but continue and finish the workflow. 3) Perform 3D rotational programs that include real time subtraction from the exam room. The display on the live monitor in the exam room is not affected by this problem. To resolve the issue, the update AX028/13/P (VC20x/VC21B), will be made available around July 2013, and scheduling an appointment for implementation of the update with Siemens Customer Service organization was recommended. If this device/equipment is no longer in theirr possession, customers were asked to forward this safety notice to the new owner and inform Siemens of the new user's identity.
Quantity in Commerce 29
Distribution Nationwide Distribution and Puerto Rico
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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