Vision RT TrueBeam and Edge Radiotherapy Systems Recalled for Parameter Errors
Vision RT Ltd is recalling 47 TrueBeam and EDGE radiotherapy systems because unintended changes to couch rotation parameters were discovered during patient set-up.
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 3/5 (High).
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 high-risk medical device where a defect could lead to serious injury, but the source text explicitly states that no patient harm was reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vision RT Ltd is recalling 47 units of the TrueBeam Radiotherapy Delivery System and EDGE Radiotherapy Delivery System. These devices are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The recall was initiated after the manufacturer received three reports from different sites indicating that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System (OSMS). The source text explicitly states that no patient harm was reported in any of these cases.
The affected devices were distributed in the United States, Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and the United Kingdom. No product was distributed to US government accounts. Specific serial numbers for the affected units are listed in the agency's recall record.
The recalled product
- Product
- TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is…
- Manufacturer
- Vision RT Ltd
- Affected units
- 47
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Vision RT Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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