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Z-1341-2019 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1341-2019 was initiated by Siemens Medical Solutions USA, Inc on April 9, 2019 and is designated Class II. Reason for recall: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. The recall status is terminated (terminated April 23, 2020). Affected quantity: 459 (116 US).

Recall Details

Product Type: Devices
Report Date: May 22, 2019
Initiation Date: April 9, 2019
Termination Date: April 23, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 459 (116 US)

Product Description

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.

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.

Code Information

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