iGUIDE System recall
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Why was iGUIDE System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software iGUIDE 2.1 and 2.2
- Product
- iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
- Recalling firm
- Elekta, Inc.
- Quantity
- 20
- Distribution
- IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
- Recall date
- June 1, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)