FDA Medical Device Recalls (openFDA)
Siemens AG/Siemens Healthcare GmbH: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Recall number
- Z-2242-2024
- Recalling firm
- Siemens AG/Siemens Healthcare GmbH
- Product
- ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Status
- Open, Classified
- Initiated
- 2024-06-26
- Posted
- 2024-07-02
- Terminated
- not on file
- Reason
- A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
- Root cause
- Software design
- Action
- Inform customers of the temporary workaround to mitigate the issue: Take any action which will lead to a change of the prefiltration prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program or change to water values due to steeper angulation. This will help to avoid the occurrence of this issue. Siemens Medical Solutions will contact customers to arrange a date to distribute a software update to permanently resolve the defect.
- Quantity
- 201 units in total
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
- Lot, serial or model codes
- ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325
- 510(k) numbers
- ["K230950"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3004977335
- Firm city
- Forchheim
- Firm state
- not on file
- Firm country
- Germany
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