—#80569

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: All units of these product numbers. Software version 6.1

Why it was recalled

The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-03-06
Posted by FDA: 2011-04-15
Terminated: 2011-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.