FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
- Recall number
- Z-0163-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
- Status
- Terminated
- Initiated
- 2008-08-25
- Posted
- 2008-10-20
- Terminated
- 2008-10-20
- Reason
- Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
- Root cause
- Equipment maintenance
- Action
- Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.
- Quantity
- 7 units
- Distribution
- Nationwide distribution including states of CA, IN, KY, UT, VA and WI.
- Lot, serial or model codes
- Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135.
- 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