Siemens Medical Solutions USA, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
All units of these product numbers. Software version 6.1
Products Sold
All units of these product numbers. Software version 6.1
Siemens Medical Solutions USA, Inc is recalling Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Prod due to The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026