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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee multipurpose

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  Class 2 Device Recall Artis zee multipurpose see related information
Date Initiated by Firm February 18, 2016
Create Date August 29, 2017
Recall Status1 Terminated 3 on November 17, 2017
Recall Number Z-3097-2017
Recall Event ID 77908
510(K)Number K073290  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic
AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Code Information Artis zee multi-purpose - Serial number: 157660 158170 130017 157698 158108 157657 157988 157690 158091 157616 157710 158132 157677 157615 157700 157977 157602 158183 157642 158121 157975 157969 157579 157573 157650 157671 157713 158080 130013 157928 157696 157989 157644 157648 157999 158066 158180 158032 158134 130019 157601 157992 157625 158079 157600 157604 157634 157635 158081 158104 158105 158056 157965 157570 157658 157594 158027 157706 158042 157674 157907 158043 157668 158019 157692 157936 157984 158113 157707 157708 157661 157688 158136 157987 158028 157702 158191 158138 158126 157704 158186 157667 158133 157645 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 18, 2016, to affected customers informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an appointment to schedule the work For questions regarding this recall call 610-.448-6461.
Quantity in Commerce 986 units in USA
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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