Date Initiated by Firm | May 08, 2015 |
Date Posted | May 27, 2015 |
Recall Status1 |
Terminated 3 on April 11, 2017 |
Recall Number | Z-1679-2015 |
Recall Event ID |
71289 |
510(K)Number | K120387 K130617 K140187 |
Product Classification |
System,planning,radiation therapy treatment - Product Code MUJ
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Product | RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment
Product Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. |
Code Information |
Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4 |
Recalling Firm/ Manufacturer |
RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
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Manufacturer Reason for Recall | RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing. |
FDA Determined Cause 2 | Software Design Change |
Action | RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information. |
Quantity in Commerce | Domestic: 539 units |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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 = MUJ
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