The FDA announced on August 3, 2023, that Accuray Incorporated is recalling the upper roller bracket (part number 1088370) for the Gen2 gantry enclosure of the Radixact Treatment Delivery System. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
- Brand: Accuray
- Product: Upper roller bracket for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
- Part number: 1088370
- UDI-DI: 00811376030009
- Serial numbers: 4010505, 4010506, 4010507, 4010508, 4010509, 4010510, 4010511, 4010513, 4010515, 4010516, 4010517, 4010518, 4010519, 4010521, 4010522, 4010523, 4010524, 4010525, 4010526, 4010527, 4010528, 4010529, 4010530, 4010531, 4010532, 4010533, 4010536, 4010537, 4010538, 4010539, 4010541, 4010542, 4010543, 4010544, 4010545, 4010546, 4010548, 4010549, 4010550, 4010551, 4010552, 4010553, 4010554, 4010555, 4010556, 4010557, 4010558, 4010559, 4010560, 4010561, 4010562, 4010563, 4010564, 4010565, 4010566, 4010567, 4010568, 4010569, 4010570, 4010571, 4010573, 4010574, 4010577, 4010579, 4010582, 4010583, 4010584, 4010585, 4010586, 4010587, 4010588, 4010589, 4010590, 4010592, 4010593, 4010594, 4010596, 4010599, 4010607, 4010600, 4010601, and 4010609
- Units affected: 82
The hazard
According to the FDA, the upper roller bracket may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system. This condition could result in possible injury to the service personnel.
Context
GovInfoNow's records show Accuray Incorporated has 9 other recalls on record since November 17, 2017. Other recent recalls of similar products include Molift 4-Point Sling Bars Recall: Deformation Risk During Use (November 17, 2025), Philips Spectral CT 7500 on Rails Recall: Unsecured Rotor Risk (January 7, 2026), and Canon Alphenix X-ray Systems Recall: Loose Fixing Screws Risk Equipment Failure (August 4, 2026).