FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dMP, Model number 7555365 angiographic x-ray systems
- Recall number
- Z-0484-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dMP, Model number 7555365 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
- 32 unit
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers: 57004, 57008, 57009, 57012, 57016, 57024, 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57116, 57117, 57124, 57144, 57155, 57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204.
- 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