medical Class II Updated 2019-05-22

Siemens Medical Solutions USA, Inc recalls Artis Q (material 10848280, 10848281, 10848282) - Product Us

Recalled Product

Artis Q (material 10848280, 10848281, 10848282) - Product Usage: 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 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 and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.


Hazard / Issue

In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number 103302 103279 103285 103286 103277 103295 103310 103293 109569 109502 109592 109523 109583 109512 109496 109542 109589 109552 109598 109500 109504 109505 109526 109565 109536 109520 109501 109507 109567 109541 109515 109551 109518 109538 109531 109532 109543 109503 109497 109527 109560 109564 109558 109524 109525 109591 121471 121467 121501 121445 121459 121490 121461 121491 121455 121504 121457 121460 121493 121487 121472 121478 121479 121470 121485 121486 121462 121468 121505 121506 121502
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