MRIdian ViewRay Radiation Therapy System recall: Software Issue
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for…
Why was MRIdian ViewRay Radiation Therapy System recalled?
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
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 number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105
- Product
- MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for…
- Recalling firm
- Viewray Incorporated
- Quantity
- 5 units
- Distribution
- Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)