ViewRay Treatment Planning Software Recalled for Location Calculation Failure
ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where functional failures could lead to significant injury or improper treatment.
Plain-English summary
Viewray Incorporated is recalling three units of Treatment Planning and Delivery System Software version 3.6. The software is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
The recall was initiated because the software was failing to determine new patient locations if imaging is not enabled during treatment. This defect could impact the accuracy of treatment delivery.
The affected software units have Catalog/Part Number 10000 and Serial Numbers 100, 101, and 102. These units were distributed in the states of California, Missouri, and Wisconsin. Healthcare facilities should contact Viewray Incorporated for further instructions regarding the recall.
The recalled product
- Product
- Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Manufacturer
- Viewray Incorporated
- Affected units
- 3
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)
- Catalog/Part Number: 10000
- Serial #'s: 100
- 101
- and 102
Distribution
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