Z-0809-06

AXIOM Artis X-ray systems running software versions VB11K and VB22G

Name: Z-0809-06 AXIOM Artis X-ray systems running software versions VB11K and VB22G
Creator: Siemens Medical Solutions USA, Inc
Published: 2006-03-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2006-03-10 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis X-ray systems running software versions VB11K and VB22G on 2006-03-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0809-06
Status: Terminated
Initiated: 2006-03-10
Posted: 2006-04-26
Terminated: 2006-08-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis X-ray systems running software versions VB11K and VB22G
Product code: IZI System, X-Ray, Angiographic
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code IZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)