Upper roller bracket for Radixact gantry enclosure may lack adequate service clearance
Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.
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: This is a Class II FDA medical device recall with no reported injuries. The hazard—possible injury from inadequate clearance during service—is theoretical rather than confirmed, placing this in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling the upper roller bracket (part number 1088370) for the Gen2 gantry enclosure of the Radixact Treatment Delivery System.
The recall was initiated because the bracket may not provide sufficient clearance for service personnel to safely use a jib crane when moving components during system maintenance. This creates a possible risk of injury to service personnel.
A total of 82 recalled units were distributed worldwide. Within the United States, distribution occurred in California, Georgia, Illinois, Louisiana, New Jersey, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, and Washington. International distribution includes Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
Healthcare facilities with affected Radixact systems can contact Accuray Incorporated to identify affected units and receive remediation guidance.
The recalled product
- Product
- Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
- Manufacturer
- Accuray Incorporated
- Category
- Medical Device
- Hazard
- inadequate-clearance
- injury-risk
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 (20)
- UDI-DI number 00811376030009. Serial numbers 4010505
- 4010506
- 4010507
- 4010508
- 4010509
- 4010510
- 4010511
- 4010513
- 4010515
- 4010516
- 4010517
- 4010518
- 4010519
- 4010521
- 4010522
- 4010523
- 4010524
- 4010525
- 4010526
- 4010527
Distribution
Distributed nationwide across the United States.
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