FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
- Recall number
- Z-2108-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
- Status
- Terminated
- Initiated
- 2013-04-26
- Posted
- 2013-08-28
- Terminated
- 2014-11-06
- Reason
- The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300.
- Quantity
- 178
- Distribution
- US Distribution including the states of PA, NJ, DC, VA, MD and DE.
- Lot, serial or model codes
- Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.
- 510(k) numbers
- ["K021021"]
- 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