iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
- Company
- Elekta, Inc.
- Recall Initiated
- May 12, 2016
- Posted
- May 23, 2016
- Terminated
- July 16, 2021
- Recall Number
- Z-1705-2016
- Quantity
- 20
- Firm Location
- Atlanta, GA
Reason for Recall
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.
Distribution
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
Lot / Code Info
Software iGUIDE 2.1 and 2.2
Root Cause
Software design
Action Taken
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 for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.