ViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement
ViewRay is recalling four MRIdian Radiation Therapy Systems because the patient couch may move unexpectedly if an encoder fails and the system is restarted.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could cause unexpected movement and potential injury, but the source text does not report any actual injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ViewRay Incorporated is recalling four units of the MRIdian ViewRay Radiation Therapy System. The recall involves serial numbers 100, 101, 102, and 105. These systems are 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 ViewRay discovered that if an encoder breaks or fails on the Patient Handling System (PHS, or couch), the couch could move unexpectedly when an attempt is made to restart the system. This unexpected movement presents a risk of injury to patients or staff.
The affected units were distributed in the United States to California, Missouri, and Wisconsin, and internationally to Korea. Healthcare facilities using these systems should contact ViewRay for further instructions on how to address the defect.
The recalled product
- Product
- MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is 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
- 4
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 (5)
- Catalog/Part Number: 10000
- Serial Numbers: 100
- 101
- 102
- & 105
Distribution
Related recalls
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See all →- SevereViewRay MRIdian Radiation Therapy System Software Recall
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