ViewRay MRIdian Radiation Therapy System Software Recall
ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, and the defect involves a radiation therapy system where a failure to shift the couch could result in dose delivery to the wrong location, posing a significant risk of injury.
Plain-English summary
ViewRay Incorporated is recalling 5 units of the MRIdian ViewRay Radiation Therapy System. The affected systems are identified by Model Number 10000 and Serial Numbers 100, 101, 102, 104, and 105. These units were distributed in the United States (including California, Florida, Missouri, and Wisconsin) and internationally to the Republic of Korea and The Netherlands.
The recall is due to a software defect in the treatment planning and delivery system. When a user edits the isocenter or couch position in the treatment workflow and re-optimizes the plan, the software does not prompt the user to shift the couch to the new isocenter. This failure creates a potential risk that radiation dose may be delivered to the initial isocenter rather than the intended new location.
The FDA has classified this recall as Class II. Users of the affected systems should contact ViewRay Incorporated for further instructions on how to address the software issue.
The recalled product
- Product
- MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is
- Manufacturer
- Viewray Incorporated
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100
- 101
- 102
- 104 & 105
Distribution
Related recalls
Same manufacturer · Viewray Incorporated
See all →- HighViewRay MRIdian Radiation Therapy System Recalled for Treatment Interruption Error
FDA (Devices) · 2016-02-24
- HighViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement
FDA (Devices) · 2015-10-21
- SevereViewRay Patient Handling System Software Recalled for Unexpected Movement
FDA (Devices) · 2015-07-22
- SevereViewRay Treatment Planning Software Recalled for Location Calculation Failure
FDA (Devices) · 2015-07-08
- SevereViewRay Radiation Therapy System Recalled for Coordinate Correction Error
FDA (Devices) · 2015-05-13
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25