FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Artis MP, Angiographic x-ray system, model number 5904466
- Recall number
- Z-0578-2007
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Artis MP, Angiographic x-ray system, model number 5904466
- Status
- Terminated
- Initiated
- 2007-01-31
- Posted
- 2007-03-08
- Terminated
- 2009-05-05
- Reason
- C-arm gantry could rapidly descend without command during use.
- Root cause
- Other
- Action
- In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.
- Quantity
- 62 units
- Distribution
- The products were shipped to medical facilities nationwide.
- Lot, serial or model codes
- Model number number 5904466 - serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20158, 20165, 20170, 20171, 20172, 20175, 20178, 20179, 20180, 20181, 20182, 20183, 20185, 20188, 20196, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, and 20303.
- 510(k) numbers
- ["K010721"]
- 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