Recall Z-0281-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
| Date | Nov 14, 2013 (initiated Oct 23, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13. |
| Quantity | 195 units domestically |
| Distribution | US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia. |
| FDA record | Open on fda.gov |