ViewRay System recall: Software Issue
ViewRay System, Radiation Therapy System
Why was ViewRay System recalled?
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
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?
M/N 10000, S/N 100 only
- Product
- ViewRay System, Radiation Therapy System
- Recalling firm
- Viewray Incorporated
- Quantity
- 1
- Distribution
- US distribution to MO.
- Recall date
- May 13, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)