Viewray MRIdian Linac Radiation Therapy System Recall for Dose Calculation Discrepancy
Viewray is recalling 17 MRIdian Linac Radiation Therapy Systems due to a discrepancy between optimization and planning forward dose calculations.
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 high-risk medical device (radiation therapy system) with a technical defect affecting dose calculation. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Viewray, Inc. is recalling 17 units of the MRIdian Linac Radiation Therapy System, Model 20000. The recall was initiated because a discrepancy can occur between optimization and planning forward dose calculations between adaptive optimizations and AQA dose calculations.
The affected devices were distributed to facilities in Florida, Illinois, Michigan, Missouri, New York, and Wisconsin. Foreign distribution included Denmark, France, Germany, the Netherlands, South Korea, Switzerland, Turkey, and the UAE. The specific serial numbers for the recalled units are 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, and 228.
Healthcare providers should contact Viewray, Inc. for instructions on how to address the dose calculation discrepancy. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- MRIdian Linac Radiation Therapy System, Model 20000.
- Manufacturer
- Viewray, Inc.
- Hazard
- Affected units
- 17
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 (17)
- Serial Numbers 101
- 107
- 201
- 202
- 203
- 204
- 205
- 206
- 209
- 211
- 213
- 214
- 217
- 221
- 223
- 225
- 228.
Distribution
Related recalls
Same manufacturer · Viewray, Inc.
See all →- HighViewRay MRIdian Linac System software anomalies in non-English versions
FDA (Devices) · 2021-06-16
- HighViewRay MRIdian Linac System Recalled for Potential Burn Injury Risk
FDA (Devices) · 2020-12-02
- HighViewRay MRIdian System Recalled for Potential Burn Injury Risk
FDA (Devices) · 2020-12-02
- HighViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors
FDA (Devices) · 2020-05-06
- HighViewray MRIdian Linac Radiation Therapy Systems Recalled for Missing Transfer Instructions
FDA (Devices) · 2019-12-18
Same hazard · dose calculation error
See all →- HighRadiation Therapy Planning System Density Calculation Inconsistency in RayStation
FDA (Devices) · 2025-02-26
- HighRayStation radiation therapy planning software density uncertainty calculation inconsistency
FDA (Devices) · 2025-02-26
- HighMedical device recall: RayStation radiation therapy software dose calculation inconsistency
FDA (Devices) · 2025-02-26
- HighRayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
FDA (Devices) · 2025-02-26
- HighRadiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations
FDA (Devices) · 2025-02-26
Similar recalls
- HighViewray MRIdian Linac Radiation Therapy Systems Recalled for Missing Transfer Instructions
FDA (Devices) · 2019-12-18
- HighViewRay MRIdian Linac System Recalled for Potential Burn Injury Risk
FDA (Devices) · 2020-12-02
- HighViewRay MRIdian Linac System software anomalies in non-English versions
FDA (Devices) · 2021-06-16
- HighViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors
FDA (Devices) · 2020-05-06
- HighViewRay MRIdian Radiation Therapy System Recalled for Treatment Interruption Error
FDA (Devices) · 2016-02-24
- SevereViewRay MRIdian Radiation Therapy System Software Recall
FDA (Devices) · 2016-04-06