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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee biplane

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  Class 2 Device Recall Artis zee biplane 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-3092-2017
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 biplane- Serial number: 154502 154616 154536 154096 154454 154715 154789 154779 154532 131017 154157 154722 154721 154571 154074 154612 154090 154658 154686 154095 154567 154480 154093 154086 154704 153882 154727 154408 154509 154079 154462 154098 154073 154076 154792 154156 154799 154814 154783 154731 154683 153878 154565 154653 154671 154556 154406 154518 154778 154685 137650 131005 154633 154020 154058 154155 153884 154453 154708 154579 154762 154034 154018 154560 154596 154066 154663 154544 154614 154048 154800 154592 154684 154087 154085 154471 154606 154604 154456 154687 154707 154459 131000 154581 154423 154546 154052 154028 154084 154732 154709 154678 131011 154430 154501 154514 154075 154064 154562 154585 154044 154770 154035 154056 154785 154425 154082 154429 154055 154631 154476 154088 154067 154584 154610 154094 154576 154089 154041 154739 154077 154602 154097 154615 154572 154564 
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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