The Recall Desk
SevereFDA (Devices)·Z-1580-2015·Announced 2015-05-13

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Radiation Therapy
Hazard
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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