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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation software version 4.0.3.4

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 Class 2 Device Recall RayStation software version 4.0.3.4see related information
Date Initiated by FirmApril 25, 2014
Date PostedJune 17, 2014
Recall Status1 Terminated 3 on June 26, 2017
Recall NumberZ-1806-2014
Recall Event ID 68162
510(K)NumberK130617 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductRayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Code Information Software version 4.0.3.4
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
For Additional Information ContactFreddie Cardel
877-778-3849
Manufacturer Reason
for Recall		This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
FDA Determined
Cause 2		Software design
ActionOn April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.
Quantity in Commerce25 sites/245 units (US), 25 sites/124 units (foreign)
DistributionWorldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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