RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and

FDA device recall Z-1481-2014 · posted 2014-04-21 · Terminated

Recall details

Recalling firm: RAYSEARCH LABORATORIES AB
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.
Action taken: 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.
Root cause: Software design
Status: Terminated
Product code: MUJ
Quantity affected: 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,
Date initiated: 2014-02-14
Date posted: 2014-04-21
Date terminated: 2017-02-15
Location: Stockholm, Sweden

Recalls and clearances share one API, with change alerts when new recalls post.