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.
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510(K) Database | 510(K)s with Product Code = IYE
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