Vision RT AlignRT System Recalled for Potential Interlock Failure
Vision RT is recalling AlignRT systems due to a potential failure to assert interlock, which could affect radiation safety during treatment.
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 potential failure of a safety interlock in a radiation therapy device, which poses a risk of harm if radiation is delivered incorrectly. No injuries or illnesses are reported in the source text, placing this in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vision RT Inc is recalling AlignRT systems, a prescription medical device used for simulation, setup, and stereotactic radiosurgery. The recall is issued because the system may fail to assert an interlock, a safety mechanism designed to prevent radiation delivery under unsafe conditions.
The recall affects seven units distributed in the United States and internationally. In the US, units were distributed in California, Minnesota, Texas, and Utah. One unit was distributed in the Republic of Ireland. The affected software versions are 5.0.1738 and 5.0.1742. Affected serial numbers include 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, and 249-0139.
Healthcare facilities using these systems should contact Vision RT Inc for instructions on how to address the potential interlock failure. Patients who have undergone treatment with these systems should consult their healthcare provider if they have concerns regarding their treatment safety.
The recalled product
- Product
- AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
- Manufacturer
- Vision Rt Inc
- Affected units
- 7
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 (6)
- 248-066
- 248-088
- 249-0059
- 249-0133
- 249-0134
- 249-0139.
Distribution
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