FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Aristos FX. Model number 74 14 803
- Recall number
- Z-0990-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Aristos FX. Model number 74 14 803
- Status
- Terminated
- Initiated
- 2005-06-10
- Posted
- 2005-07-13
- Terminated
- 2006-08-30
- Reason
- potential issue (system may lock up) when repeating patient registrations
- Root cause
- Other
- Action
- The recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.
- Quantity
- 72 units
- Distribution
- Nationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and WI.
- Lot, serial or model codes
- Serial numbers 1001 through 1003, 1005 through 1047, and 1049 through 1247.
- 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