Patient Handling System — Class II medical device recall Z-2085-2015
Terminated recall by Viewray Incorporated, reported 2015-07-22, distributed nationwide. ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
| Recall number | Z-2085-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray Incorporated, Oakwood Village, OH, United States |
| Recall initiated | 2015-04-01 |
| Classified | 2015-07-16 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Serial numbers | 100, 101, 102 |
| Model numbers | 10000 |
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 for recall
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2085-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.