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 Verify and Record software with XLINK option for Varian MLC

  • 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 Verify and Record software with XLINK option for Varian MLC see related information
Date Initiated by Firm July 07, 2006
Date Posted August 11, 2006
Recall Status1 Terminated 3 on March 26, 2008
Recall Number Z-1401-06
Recall Event ID 35982
510(K)Number K981313  
Product Classification Impac MultiAccess Sequencer - Product Code IYE
Product LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
Code Information Site Numbers: 93-0452, 93-0494, 93-0571, 93-0724, 93-0881, 93-0894, 93-0902, 93-0443, 93-0776, 93-0677, 93-1032, 93-0880, 93-0010, 93-0095, 93-0432, 93-0991, 93-0711, 93-0007, 93-0641, 93-0356, 93-0391, 93-0015, 93-0118
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
Manufacturer Reason
for Recall		 Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.
FDA Determined
Cause 2		 Software design
Action The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.
Quantity in Commerce 23 units
Distribution Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland
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 = IMPAC MEDICAL SYSTEMS, INC.
-
-