CLASS II Device recall · Reported 21 Oct 2015 · FDA Enforcement Report
MRIdian¿ ViewRay¿ Radiation Therapy System recalled
Viewray Incorporated is recalling MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic, distributed nationwide in the US. The recall was initiated on 27 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0115-2016
- FDA event ID
- 72166
- Recalling firm
- Viewray Incorporated, Oakwood Village, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2015
- FDA classified
- 9 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 27 Aug 2015 | Recall initiated by company | |
| 9 Oct 2015 | Classified by FDA | +43 days |
| 21 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Where it was distributed
US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
Questions about this recall
Is MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic recalled?
Yes. Viewray Incorporated recalled MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic on 27 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0115-2016.
Why was it recalled?
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Which lots are affected?
Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
Where was it sold?
US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Viewray Incorporated
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MRIdian ViewRay Radiation Therapy System recalled | Viewray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | MRIdian ViewRay Radiation Therapy System, Viewray Inc recalled | Viewray Incorporated | Other | Nationwide |
| Device | CLASS II | Patient Handling System (Motion Control recalled by Viewray Incorporated | Viewray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Treatment Planning and Delivery System recalled by Viewray Incorporated | Viewray Incorporated | Device Malfunction | CA, MO, WI |
| Device | CLASS II | System, Radiation Therapy System recalled by Viewray Incorporated | Viewray Incorporated | Device Malfunction | MO |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |