Z-1095-04

Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163

Name: Z-1095-04 Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-04-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-04-01 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163 on 2004-04-01. The reason FDA records is "Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1095-04
Status: Terminated
Initiated: 2004-04-01
Posted: 2004-07-20
Terminated: 2004-09-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported accurately to certain CT or MR images.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm has issued a letter to their Siemens Service Engineers to visit each affected sites, in order to correct the software problems. Additionally, a letter advising of the software problems was also sent to the Radiology Director at the affected sites, informing them of the 'Customer Safety Advisory' and the pending visit of the Seimens Service Engineers to perform a software update. Along with these letters, is a set of instructions detailing the potential risks and that a representative from the recalling firm will be contacting the medical facilities.
Distribution: Nationwide. The product was shipped to various medical facilities, in the following states, AK, GA, FL, IA, MA, MI, MO, NH, NJ, NY, NV, OK, PA, TX, and WI.
Product codes and lots: All software associated with Image Navigator feature in Magic View

Product code LLZ

K935694Class IISienet Diagnostic Reporting Console Va02 UpgradeSiemens Medical Solutions USA, Inc. / cleared 1994-03-07

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)