Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
FDA Recall Z-1343-2022 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2022-05-24
Date Terminated2025-01-22
Product Quantity233 worldwide; 32 US
Reason for Recall
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.
Firm Action
On May 24, 2022, the firm mailed Urgent Medical Device Correction letters to affected consignees. Customers were informed that if the system is not used regularly, please ensure that the system is switched on in due time before any use to check the status. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient.
The firm will replace the Bios battery and the service interval will be shortened to two years. The firm will contact customers to arrange a date to perform the correction.
Customers may call the service organization at 1-800-888-7435 to schedule an earlier appointment.
Root Cause
Component design/selection
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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