FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
- Recall number
- Z-2587-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
- Status
- Terminated
- Initiated
- 2014-06-05
- Posted
- 2014-09-24
- Terminated
- 2015-04-06
- Reason
- There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
- Root cause
- Device Design
- Action
- Siemens sent an Important Safety Information letter dated June 5, 2014, to affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to observe this safety notice and comply with the corresponding measures until the update has been fully completed.
- Quantity
- 1067
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959
- 510(k) numbers
- ["K010721","K073290"]
- PMA numbers
- not on file
- Product code
- IZI
- 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