FDAFDA · Food and drugs·Recall number Z-1705-2016
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Published June 1, 2016 · Recall initiated: May 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
- Lot
- Software iGUIDE 2.1 and 2.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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