MRIdian ViewRay Radiation Therapy System recall
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Why was MRIdian ViewRay Radiation Therapy System recalled?
The system loaded a completion fraction in the incorrect order after a treatment interruption.
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?
Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105
- Product
- MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
- Recalling firm
- Viewray Incorporated
- Quantity
- 5 units
- Distribution
- US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
- Recall date
- February 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)