PlainRecalls
FDA Devices Moderate Class II Terminated

Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Reported: April 6, 2016 Initiated: February 19, 2016 #Z-1311-2016

Product Description

Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Reason for Recall

Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.

Details

Units Affected
1757 systems
Distribution
Nationwide distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1757 systems.
Why was this product recalled?
Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. 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-1311-2016.