PlainRecalls
FDA Devices Moderate Class II Terminated

AXIOM Artis zee/zeego, system, x-ray, angiographic 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/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpo

Reported: April 6, 2016 Initiated: February 18, 2016 #Z-1284-2016

Product Description

AXIOM Artis zee/zeego, system, x-ray, angiographic 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/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.

Reason for Recall

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.

Details

Units Affected
986 systems in total
Distribution
US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
AXIOM Artis zee/zeego, system, x-ray, angiographic 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/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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 986 systems in total.
Why was this product recalled? ▼
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1284-2016.

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