ViewRay Radiation Therapy System Recalled for Coordinate Correction Error
Viewray Incorporated is recalling one ViewRay System due to a software error affecting coordinate correction for non-standard patient positions.
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, which corresponds to a Severe severity score (4) under the rubric, as it involves a defect that could cause temporary or medically reversible health consequences.
Plain-English summary
Viewray Incorporated is recalling one unit of the ViewRay System, a Radiation Therapy System, under FDA recall number Z-1580-2015. The recall involves a specific unit with Manufacturer Number 10000 and Serial Number 100, which was distributed in the United States to Missouri.
The recall was initiated because the system's software did not correctly use the Radiation Therapy to Magnetic Resonance (MR) coordinate correction for patients positioned in non-Head First Supine (HFS) orientations. This software defect resulted in a slice mismatch error.
No specific instructions for consumers are provided in the source text, as this is a medical device recall managed by the manufacturer and regulatory agencies.
The recalled product
- Product
- ViewRay System, Radiation Therapy System
- Manufacturer
- Viewray Incorporated
- Affected units
- 1
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 (2)
- M/N 10000
- S/N 100 only
Distribution
Distributed in 1 state:
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