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U.S. Department of Health and Human Services

Class 2 Device Recall Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0

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  Class 2 Device Recall Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0 see related information
Date Initiated by Firm February 14, 2014
Date Posted April 21, 2014
Recall Status1 Terminated 3 on February 15, 2017
Recall Number Z-1481-2014
Recall Event ID 67535
510(K)Number K100552  K120387  K130617  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Code Information Versions: 2.0.0.15, 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.
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
For Additional Information Contact Freddie Cardel
877-778-3849
Manufacturer Reason
for Recall		 RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
FDA Determined
Cause 2		 Software design
Action RaySearch Laboratories sent a Field Safety Notice, Medical Device Correction letter dated February 14, 2014 to their customers via email. The letter identified the affected product, problem and actions to be taken by the user. Customers with questions may contact Freddie Cardel, Director of Customer Support at 1-877-778-3849 or via email at freddie.cardel@raysearchlabs.com.
Quantity in Commerce 251 units (148 units domestically & 103 units internationally)
Distribution Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
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 = MUJ and Original Applicant = RAYSEARCH LABORATORIES AB
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