RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Recall Initiated
- May 18, 2020
- Terminated
- August 6, 2021
- Recall Number
- Z-2347-2020
Reason for Recall
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Distribution
US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
Lot / Code Info
UDI # 07350002010204 Build number: 8.1.1.8
Root Cause
Software design
Action Taken
On May 18, 2020, RaySearch Laboratories emailed an Urgent Field Safety Notice, Medical Device Correction #60564 letter to their customers. The letter listed the following actions to be taken by the users: always use the MC dose engine for final dose calculation, in robustness analysis, and dose tracking if possible (the MC dose engine is available in versions RayStation 6.0 and later); if the pencil beam dose engine is used for final dose calculation, ensure that all spots intersect the External ROI as seen in the Beams Eye View (BEV) of the Plan optimization module; if they do not, expand the External ROI so that all spots do intersect the External ROI, and re-optimize the plan if necessary; if the MC dose engine is used for final dose calculation, and hot spots related to tangential fields are observed, expand the External ROI so that the central axis of all spots intersect the External ROI and re-optimize the plan; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s). RaySearch Laboratories asked all customers to confirm that they have read and understood the notice by replying to the notification email.