FDA Device recall Z-2085-2015
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for le…
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for le… by Viewray, citing viewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2085-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-01 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Viewray |
| Distribution | US |
Product
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Identifiers
| code_info | Model #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-2085-2015%22
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