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