Recall Z-2393-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2393-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-07-13, terminated 2017-11-08. It names one FDA 510(k) clearance: K010721. Product: AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are 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, Artis zee / zeego and Artis 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, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.. Reason: The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-13
Terminated: 2017-11-08
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K010721 — AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMSiemens Medical Corp.·cleared 2001-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are 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, Artis zee / zeego and Artis 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, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.

Reason for recall

The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.