ViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors
Viewray, Inc. is recalling 32 units of MRIdian TPDS software due to a defect that may cause incorrect dose calculations during treatment planning.
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 is classified as FDA Class II. The hazard involves a risk of harm (incorrect radiation dose) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Viewray, Inc. is recalling 32 units of the ViewRay System (Model No. 10000 and 20000) MRIdian System Treatment Planning and Delivery System (TPDS) software. The recall affects specific serial numbers for both models, which were distributed worldwide, including in the United States and various international locations.
The software contains a defect where registering dose and structures in the treatment delivery workflow can result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy. This misalignment may not be obvious to the user. During plan re-optimization, the software may incorrectly account for the previously delivered dose, potentially resulting in unexpectedly higher or lower doses than intended for subsequent treatment plans. In some cases, the registration fails to align the dose with the image, preventing the user from proceeding.
The recall is classified as Class II by the FDA. Users of the affected software should contact Viewray, Inc. for an Urgent Device Correction to resolve the alignment issue.
The recalled product
- Product
- ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
- Manufacturer
- Viewray, Inc.
- Affected units
- 32
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 (20)
- Model No.10000 - Serial No's:. 100
- 104
- 105
- 112
- 113 Model No. 20000 - Serial No's: 101
- 102
- 107
- 108
- 200
- 201
- 203
- 204
- 206
- 207
- 209
- 211
- 213
- 214
- 215
- 216
Distribution
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