Recall Z-2691-2016 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
| Date | Aug 30, 2016 (initiated Aug 18, 2016) |
| Status | Terminated |
| Reason | Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position. |
| Root cause | Nonconforming Material/Component |
| Action | Elekta sent an Important User Notice 618-03-303-025 to affected customers on 8/18/2016. The notice identified the affected product, problem, clinical impact, solution and actions to be taken. The Notice reminds users that the Interlock Check is not possible during 3D Workflow as iGUIDE is not in use. The notice reminds users that if iGUIDE is not being used - (A) Ensure the HexaPOD is at its pre-defined 3D position before treatment, and (B) Ensure the External Inhibit LED at the EnableSwitch Board is off. For questions contact your local Elekta office. |
| Quantity | 13 |
| Distribution | Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072079 | IGUIDE SYSTEM Medical Intelligence Medizintechnik-GmbH-An Elekta, Aug 14, 2007 |