—#194338

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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.

Timeline

Recall initiated: 2022-05-24
Terminated: 2025-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194338. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.