Recall Z-2697-2017 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, orbital tumors, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular sc
| Date | May 31, 2017 (initiated May 23, 2017) |
| Status | Terminated |
| Reason | If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator. |
| Root cause | Other |
| Action | Elekta sent an Urgent Important Field Safety Notice dated June 2017, to all affected customers. This notice informs users of the specific product and version numbers affected by the issue. The affected devices are spare part Gantry Module (item number 1515698). Customers are also instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative. For further questions, please call (770) 670-2422. |
| Quantity | 2 |
| Distribution | US Distribution to the states of : NY and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160440 | Leksell Gamma Knife Icon Elekta Instrument AB, Apr 20, 2016 |