FDAFDA · Food and drugs·Recall number Z-1308-2014
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
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
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Distributor
- OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
- Lot
- Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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