FDA Device recall Z-1954-2015
Treatment Planning and Delivery System Software version 3.6. ViewRay
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Treatment Planning and Delivery System Software version 3.6. ViewRay by Viewray, citing the software was failing to determine new patient locations if imaging is not enabled during treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1954-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-07 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Viewray |
| Distribution | CA, MO, WI |
Product
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason
The software was failing to determine new patient locations if imaging is not enabled during treatment.
Identifiers
| code_info | Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1954-2015%22
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