Recall Z-1724-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Synergy XVI Intended for radiation therapy treatment.
| Date | Jun 16, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | XVI can incorrectly calculate the target position of the treatment table. |
| Root cause | Software design |
| Action | Elekta is responsible for the correction of all products with this defect. 1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury. 2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014. 3. The software correction will enable verification that values have been assigned to table position parameters; f |
| Quantity | 380 US |
| Distribution | Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.