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.
FDA Recall Z-2000-2011 · Posted 2011-04-15
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-03-06
Date Terminated2011-04-15
Product Quantity17
Reason for Recall
The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
Firm 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.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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