Recall Z-1561-2016 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
| Date | Apr 19, 2016 |
| Status | Terminated |
| Reason | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame. |
| Root cause | Use error |
| Action | Elekta sent an Important User Notice (100-03-202-27) letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement Form attached. For questions contact your local Elekta office. |
| Quantity | 217 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic |
| FDA record | Open on fda.gov |