RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
This recall has been terminated (originally issued March 31, 2014).
- Recall Initiated
- February 6, 2014
- Posted
- March 31, 2014
- Terminated
- February 17, 2017
- Recall Number
- Z-1308-2014
- Quantity
- 19 units (16 units domestically & 3 units internationally)
- Official Source
- View on FDA website ↗
Reason for Recall
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Distribution
OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
Lot / Code Info
Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
Root Cause
Software Design Change
Action Taken
On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.