FDAFDA · Food and drugs·Recall number Z-0281-2014
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Published November 20, 2013 · Recall initiated: October 23, 2013
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
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Distributor
- US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
- Lot
- Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.