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.
What this means for you
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
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