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.
Other recalls by Viewray
- ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiat…
FDA Device · Class II · 2021-06-16 · Viewray - ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amp…
FDA Device · Class II · 2020-12-02 · Viewray - ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input…
FDA Device · Class II · 2020-12-02 · Viewray - ViewRay System: Model No. 10000 and 20000 for radiation treatment
FDA Device · Class II · 2020-05-06 · Viewray - MRIdian Linac Radiation Therapy System Model 10000 and 20000
FDA Device · Class II · 2019-12-18 · Viewray
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1954-2015%22
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