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Recall Observatory FDA recall evidence

Device product

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Z-1343-2022

May 24, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 90407
Status
Terminated
Classification
Class II
Quantity
233 worldwide; 32 US
Official record key
device-enforcement:Z-1343-2022

Official wording

Reason: It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.

Code information: UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, FL, IL, LA, ME, MN, MO, NC, OH, PA, SC, TN, TX, WI and the countries of Australia, Austria, Azerbaijan, Belgium, Canada, China, Finland, France, Germany, Hong Kong, India, Italy, Japan, Lebanon, Lithuania, Luxembourg, Netherlands, Poland, Portugal, South Korea, Switzerland, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.