FDA Medical Device Recalls (openFDA)
Siemens Medical Systems Inc: Axiom Artis System, X-ray, Angiographic
- Recall number
- Z-0347-03
- Recalling firm
- Siemens Medical Systems Inc
- Product
- Axiom Artis System, X-ray, Angiographic
- Status
- Terminated
- Initiated
- 2002-08-05
- Posted
- 2002-12-18
- Terminated
- 2004-10-25
- Reason
- Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
- Root cause
- Other
- Action
- A Safety Advisory Letter was sent 7/23/2002 by Siemens Medical. The letter advised the technicians of the problem and Siemens would be coming out to do the software modificaitons.
- Quantity
- 134
- Distribution
- The device was distributed to Hospitals nationwide.
- Lot, serial or model codes
- Axiom Artis System: Axiom Artis FC Model #5904433 --all serial #s Axiom Artis FA Model #5904441 --all serial #s Axiom Artis BC Model #5904649 --all serial #s Axiom Artis BA Model #5904656 --all serial #s Axiom Artis MP Model #5904466 -- all serial #s
- 510(k) numbers
- ["K010721"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2240869
- Firm city
- Iselin
- Firm state
- NJ
- 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