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.
This recall has been terminated (originally issued April 15, 2011).
- Recall Initiated
- March 6, 2009
- Posted
- April 15, 2011
- Terminated
- April 15, 2011
- Recall Number
- Z-2000-2011
- Quantity
- 17
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
Distribution
Worldwide Distribution
Lot / Code Info
All units of these product numbers. Software version 6.1
Root Cause
Software change control
Action Taken
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.