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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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Similar recalls
- HighViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement
FDA (Devices) · 2015-10-21
- HighViewRay MRIdian Radiation Therapy System Recalled for Treatment Interruption Error
FDA (Devices) · 2016-02-24
- HighViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors
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- SevereViewRay Radiation Therapy System Recalled for Coordinate Correction Error
FDA (Devices) · 2015-05-13
- SevereViewRay Treatment Planning Software Recalled for Location Calculation Failure
FDA (Devices) · 2015-07-08
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