Recall Z-1081-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Mar 6, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice November 2013 to all affected customers. Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 041 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Important Field Safety Notice is in the process of being distributed to customers advising them of the recommended Quality Assurance checks to avoid/detect the problem. The permanent solution to this problem is currently been developed. Corrective Action #2 - Permanent Solution - All users of Desktop Pro software will be informed of |
| Quantity | 489 |
| Distribution | Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Ger |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982713 | RT DESKTOP Elekta Oncology Systems, Ltd., Nov 2, 1998 |