Recall Z-2000-2011 ยท IYE Accelerator, Linear, Medical
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.
| Date | Apr 15, 2011 (initiated Mar 6, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |