FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
- Recall number
- Z-1343-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
- Status
- Terminated
- Initiated
- 2022-05-24
- Posted
- not on file
- Terminated
- 2025-01-22
- 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.
- Root cause
- Component design/selection
- 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.
- Quantity
- 233 worldwide; 32 US
- Distribution
- 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.
- Lot, serial or model codes
- UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007
- 510(k) numbers
- K181407
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28