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Recall Observatory FDA recall evidence

Device product

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.

Z-1311-2016

February 19, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 73589
Status
Terminated
Classification
Class II
Quantity
1757 systems
Official record key
device-enforcement:Z-1311-2016

Official wording

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

Code information: Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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