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U.S. Department of Health and Human Services

Class 2 Device Recall Lantis Commander

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  Class 2 Device Recall Lantis Commander see related information
Date Initiated by Firm July 10, 2019
Date Posted August 06, 2019
Recall Status1 Terminated 3 on June 03, 2020
Recall Number Z-2197-2019
Recall Event ID 83462
510(K)Number K972275  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Lantis Commander, Model # 4503178 - Product Usage:
Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.
Code Information Serial # 93-0759 93-0648 93-0662 93-1045 93-0574 93-0313 93-0501 93-0951 93-0667 93-0141 93-0786 93-0385 93-0799 93-0659 93-0861 ***added 8/14/19*** 93-0159 93-0878 93-0272 93-0596 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Rebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		 Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
FDA Determined
Cause 2		 Other
Action We strongly recommend the following: ¿ Disable Remote Desktop Protocol (RDP) or close port 3389/tcp ¿ Ensure you have appropriate backups and system restoration procedures. If you have any questions or require assistance, please contact our service organization at 1-800-888-7436.
Quantity in Commerce 15
Distribution State WV NY PA FL OK FL NJ NY IL WY NY GA NY PA PA AL NJ NY ***updated 8/14/19*** OH NC
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.
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