FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SIEMENS AXIOM Artis - AUTOMAP FUNCTION
- Recall number
- Z-1108-04
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SIEMENS AXIOM Artis - AUTOMAP FUNCTION
- Status
- Terminated
- Initiated
- 2004-06-02
- Posted
- 2004-07-20
- Terminated
- 2004-10-21
- Reason
- Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.
- Root cause
- Other
- Action
- The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.
- Quantity
- 127 units
- Distribution
- The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI,
- Lot, serial or model codes
- Model Numbers: AXIOM Artis FC 5904433 AXIOM Artis BC 5904649 AXIOM Artis MP 5904466 AXIOM Artis FA 5904441 AXIOM Artis BA 5904656 AXIOM Artis TA 7007755 AXIOM Artis FC: 10050; 10052; 10055; 10064; 10072; 10086; 10094; 10124; 10148; 10151; 10153; 10176; 10177; 10182; 10198; 10217; 10228; 10237; 10240; 10243; 10249; 10251; 10253; 10266; 10284; 10298; 10307; 10326; 10335; 10338; 10348; 10364; 10365; 10367; 10369 AXIOM Artis BC: 14007 AXIOM Artis MP: 20022; 20024; 20032; 20036; 20045; 20048; 20070; 20078; 20082; 20090; 20094; 20107; 20110; 20111; 20155; 20169; 20177; 20190; 20199; 20203; 20205
- 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