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.
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 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
- 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
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