—#158190

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

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: Artis zeego- Serial number: 160851 160879 160943 160484 160909 160502 160817 160999 160449 160852 160834 160972 160463 160944 160823 160994 160959 160913 160886 160961 160506 160845 160877 160488 160997 160864 160937 160965 160800 160455 160884 160486 160435 160451 160951 160431 160448 160925 160916 160814 160872 160493 160905 160470 160915 160447 160471 160481 160871 160989 160501 160869 160874 160862 160438 160860 160900 160450 160854 160878 160446 160957 160992 160856 160986 160432 160934 160947 160953 160903 160433 160917 160483 161005 160861 160889 160813 160998 160356 160914 160429 160930 160812 160460 160485 160443 160461 160955 160952 160954 160873 160912 160508 160968 160919 160940 160407 160876 160923 160885 160950 160910 160987 161000 160838 160494 160507 160487 160833 160967 160007 160825 160850 160942 160816 160482 160840 160462 160520 160505 160956 160445 160474 160428 160801 160498 160996 160509 161004 160978 160551 160896 160894 160865 160830 160807 160898 160477 160519 160469

Why it was recalled

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-02-18
Terminated: 2017-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158190. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.