Siemens Medical Solutions USA, Inc: 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

Recall number

Z-3092-2017

Recalling firm

Siemens Medical Solutions USA, Inc

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

Status

Terminated

Initiated

2016-02-18

Posted

not on file

Terminated

2017-11-17

Reason

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

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

986 units in USA

Distribution

Nationwide Distribution

Lot, serial or model codes

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

510(k) numbers

["K073290"]

PMA numbers

not on file

Product code

IZI

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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