FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Artis X-ray systems running software versions VB11K and VB22G
- Recall number
- Z-0809-06
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Artis X-ray systems running software versions VB11K and VB22G
- Status
- Terminated
- Initiated
- 2006-03-10
- Posted
- 2006-04-26
- Terminated
- 2006-08-30
- Reason
- The recalling firm became aware of a potential problem when imaging patients on their stomach on the AXIOM Artis X-ray Systems running software versions VB11K and VB22G. In some instances, the orientation labels could be incorrect.
- Root cause
- Other
- Action
- The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions AX011/06/S and AX013/06/S, on 3/10/2006. This informs customers of the potential problem and provides a recommendation to avoid this issue.
- Quantity
- 287
- Distribution
- Nationwide. The product was shipped to medical facilities in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL,IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI and WV.
- Lot, serial or model codes
- AXIOM Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis TC model number 7728350, AXIOM Artis TA model number 7007755, AXIOM Artis dFC model number 7412807, AXIOM Artis dFC-MN model number 7727717, AXIOM Artis dBC model number 7728392, AXIOM Artis dTC model number 7413078, AXIOM Artis dFA model number 7555373, AXIOM Artis dBA model number 7555357, AXIOM Artis dTA model number 7008605, AXIOM Artis dMP model number 7555365. Software versions VB11K and VB22G.
- 510(k) numbers
- not on file
- 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