iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Reported: June 1, 2016 Initiated: May 12, 2016 #Z-1705-2016
Product Description
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 20
- Distribution
- IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.. Recalled by Elekta, Inc.. Units affected: 20.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1705-2016.
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