Date Initiated by Firm |
February 18, 2016 |
Create Date |
August 29, 2017 |
Recall Status1 |
Terminated 3 on November 17, 2017 |
Recall Number |
Z-3099-2017 |
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 zeego.Q - Serial number: 117108 117001 117023 117021 117029 117006 117112 117034 117020 117018 117030 117026 117100 117111 117024 117113 117040 117041 117114 117014 117009 |
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
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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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