FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
- Recall number
- Z-0603-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
- Status
- Terminated
- Initiated
- 2016-11-01
- Posted
- 2016-11-17
- Terminated
- 2017-06-21
- Reason
- The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
- Root cause
- Software in the Use Environment
- Action
- Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken.
- Quantity
- 4,657 systems Worldwide
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392
- 510(k) numbers
- ["K052202"]
- 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