RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
FDA Recall Z-1481-2014 · Posted 2014-04-21
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Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-02-14
Date Terminated2017-02-15
Product Quantity251 units (148 units domestically & 103 units internationally)
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.
Firm 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 [email protected].
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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