Treatment Planning and Delivery System Software version recall: Software Issue
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions…
Why was Treatment Planning and Delivery System Software version recalled?
The software was failing to determine new patient locations if imaging is not enabled during treatment.
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?
Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102
- Product
- Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions…
- Recalling firm
- Viewray Incorporated
- Quantity
- 3
- Distribution
- Distributed in the states of CA, MO & WI.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)