Recall Z-1705-2016 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
| Date | May 23, 2016 (initiated May 12, 2016) |
| Status | Terminated |
| Reason | If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date f |
| Quantity | 20 |
| Distribution | IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, 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 |