FDAFDA · Food and drugs·Recall number Z-1307-2014
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Published April 9, 2014 · Recall initiated: February 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for dose errors due to software program errors.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Distributor
- Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.
- Lot
- MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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