Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LANTIS 6.1 Oncology Information System with MEDOne Module

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall LANTIS 6.1 Oncology Information System with MEDOne Module see related information
Date Initiated by Firm March 06, 2009
Date Posted April 15, 2011
Recall Status1 Terminated 3 on April 15, 2011
Recall Number Z-2000-2011
Recall Event ID 51504
510(K)Number K060226  
Product Classification Linear Medical Accelerator - Product Code IYE
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.
Code Information All units of these product numbers. Software version 6.1
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Mark Burgess
925-246-8407
Manufacturer Reason
for Recall		 The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old.
FDA Determined
Cause 2		 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 in Commerce 17
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
-
-