MRIdian Linac Radiation Therapy System recall
MRIdian Linac Radiation Therapy System, Model 20000.
Why was MRIdian Linac Radiation Therapy System recalled?
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
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?
Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
- Product
- MRIdian Linac Radiation Therapy System, Model 20000.
- Recalling firm
- Viewray, Inc.
- Quantity
- 17 devices
- Distribution
- Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)