FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis MP, Model number 5904466 angiographic x-ray systems
- Recall number
- Z-0483-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis MP, Model number 5904466 angiographic x-ray systems
- Status
- Terminated
- Initiated
- 2009-10-26
- Posted
- 2009-12-03
- Terminated
- 2010-01-26
- Reason
- c-arm may tilt
- Root cause
- Other
- Action
- The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.
- Quantity
- 70 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20052, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363.
- 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