FDA Medical Device Recalls (openFDA)
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 number
- Z-2000-2011
- 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.
- Status
- Terminated
- Initiated
- 2009-03-06
- Posted
- 2011-04-15
- Terminated
- 2011-04-15
- Reason
- The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
- 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
- 17
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- All units of these product numbers. Software version 6.1
- 510(k) numbers
- ["K060226"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- 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