ViewRay MRIdian Linac System recall: Software Issue
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with…
Why was ViewRay MRIdian Linac System recalled?
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
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?
French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244
- Product
- ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with…
- Recalling firm
- Viewray, Inc.
- Quantity
- 8 versions
- Distribution
- International distribution only to the countries of France, Germany, Italy, and Switzerland.
- Recall date
- June 16, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)