ViewRay MRIdian Radiation Therapy System Recalled for Treatment Interruption Error
ViewRay is recalling five MRIdian Radiation Therapy Systems because they loaded a completion fraction in the incorrect order after a treatment interruption.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impact treatment accuracy, but the source text does not report any injuries, illnesses, or fatalities, nor does it explicitly state that no injuries have occurred, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ViewRay Incorporated is recalling five units of the MRIdian ViewRay Radiation Therapy System. The recall was initiated because the system loaded a completion fraction in the incorrect order after a treatment interruption.
The affected units are Model #10000 with serial numbers 100, 101, 102, 104, and 105. These systems were distributed in the United States to California, Florida, Missouri, and Wisconsin, as well as internationally to the Republic of Korea.
The source text does not specify the actions consumers or healthcare providers should take in response to this recall.
The recalled product
- Product
- MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
- 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 (5)
- Model #: 10000
- Serial #'s: 100
- 101
- 102
- 104 & 105
Distribution
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