Z-2000-2011

Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product...

Name: Z-2000-2011 Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-03-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-03-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is... on 2009-03-06. The reason FDA records is "The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old". 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-2000-2011
Status: Terminated
Initiated: 2009-03-06
Posted: 2011-04-15
Terminated: 2011-04-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is manufactured by IMPAC Medical, Inc., Sunnyvale, CA. Medical charged-particle radiation therapy system.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
Root cause tag: software
FDA root cause: Software change control
Action: On 3/6/2009, a Safety Advisory Letter was distributed to all affected users, with a description of the problem and identifying the affected product. Customers were instructed not to use the LANTIS to calculate Creatine Clearance for any patient under two years of age. Customers should direct their questions with regards to the letter to their local Siemens Service organization. A Siemens Representative will update the systems.
Quantity in commerce: 17
Distribution: Worldwide Distribution
Product codes and lots: All units of these product numbers. Software version 6.1

Product code IYE

K060226Class IIOncor ExpressionSiemens Medical Solutions USA, Inc. / cleared 2006-03-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)