Agency classClass IIOur severity:Severe FDA (Devices)·Z-2085-2015·Announced 2015-07-22

ViewRay Patient Handling System Software Recalled for Unexpected Movement

ViewRay is recalling three units of Patient Handling System software due to a report of the couch moving unexpectedly into the bore after a reboot.

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 agency classified this as an FDA Class II recall involving a structural/mechanical defect in a medical device that could cause serious injury, meeting the criteria for a Severe rating.

Plain-English summary

ViewRay Incorporated is recalling three units of the Patient Handling System (Motion Control Software), Model #10000. The affected units have serial numbers 100, 101, and 102. This 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 after ViewRay received a report that the patient couch moved unexpectedly into the bore following a reboot of the RTCS system. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected units were distributed nationwide in the United States, specifically in the states of California, Missouri, and Wisconsin. Healthcare facilities using these systems should contact ViewRay Incorporated for further instructions on the recall and corrective actions.

The recalled product

Product: Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Manufacturer: Viewray Incorporated
Category: Medical Device — Radiation Therapy Equipment
Hazard: unexpected-movement
mechanical-failure
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)

Model #10000
Serial #'s: 100
101
and 102

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · Viewray Incorporated

See all →

Severe
ViewRay MRIdian Radiation Therapy System Software Recall
FDA (Devices) · 2016-04-06
High
ViewRay MRIdian Radiation Therapy System Recalled for Treatment Interruption Error
FDA (Devices) · 2016-02-24
High
ViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement
FDA (Devices) · 2015-10-21
Severe
ViewRay Treatment Planning Software Recalled for Location Calculation Failure
FDA (Devices) · 2015-07-08
Severe
ViewRay Radiation Therapy System Recalled for Coordinate Correction Error
FDA (Devices) · 2015-05-13

Same hazard · unexpected movement