Recall Z-1307-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
| Date | Mar 28, 2014 (initiated Feb 6, 2014) |
| Status | Terminated |
| Reason | Potential for dose errors due to software program errors. |
| Root cause | Software Design Change |
| Action | RaySearch Laboratories sent an Field Safety Notice, Medical Device Correction letter dated February 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. ACTIONS TO BE TAKEN BY THE USER A workaround that eliminates the described error is to select the discard rotations option in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. Another option is to use the ROI based deformable registration when applicable, as this functionality is not affecte |
| Quantity | 151 units Total (88 units domestically & 63 units internationally) |
| Distribution | Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain. |
| FDA record | Open on fda.gov |