Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178
FDA device recall Z-2000-2011 · posted 2011-04-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 17
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-03-06
- Date posted
- 2011-04-15
- Date terminated
- 2011-04-15
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |