Recall Z-2489-2023— Accuray Incorporated
Class II · Completed
Class II FDA medical device recall by Accuray Incorporated, initiated 2023-08-03. It names one FDA 510(k) clearance: K161146. Product: Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.. Reason: It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel..
- Recalling firm
- Accuray Incorporated
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-08-03
- Firm location
- Madison, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Reason for recall
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
Data sourced from openFDA. This site is unofficial and independent of the FDA.