RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
- Recall Initiated
- November 12, 2018
- Terminated
- April 17, 2020
- Recall Number
- Z-0679-2019
- Quantity
- 69
Reason for Recall
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
Distribution
AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI
Lot / Code Info
Software version number: 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 6.0.0.24 , 6.1.0.26, 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61 or 8.0.1.10
Root Cause
Under Investigation by firm
Action Taken
RayStation issued Field Safety Notice, Medical Device Correction #37483, on 11/12/18 via email, states issue, action to be taken and correction of software in Dec 2018.