Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
This recall has been terminated (originally issued November 14, 2013).
- Recall Initiated
- October 23, 2013
- Posted
- November 14, 2013
- Terminated
- February 17, 2017
- Recall Number
- Z-0281-2014
- Quantity
- 195 units domestically
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
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