FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Aristos X-Ray System.
- Recall number
- Z-0984-03
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Aristos X-Ray System.
- Status
- Terminated
- Initiated
- 2003-04-19
- Posted
- 2003-07-08
- Terminated
- 2004-08-25
- Reason
- software malfunction. May indicate that the image is flipped when it is not.
- Root cause
- Other
- Action
- The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.
- Quantity
- 5 units
- Distribution
- The units were shipped to medical facilities nationwide.
- Lot, serial or model codes
- part numbers 5895003 and 7414803. serial numbers 01001, 01170, 01219, 01221, and 01030.
- 510(k) numbers
- ["K013826"]
- PMA numbers
- not on file
- Product code
- KPR
- 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