Recall Z-2489-2023 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
| Date | Aug 31, 2023 (initiated Aug 3, 2023) |
| Status | Completed |
| 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. |
| Root cause | Device Design |
| Action | The recalling firm began issuing letters dated 7/19/2023 via hand-delivery by the field service engineer. The letter explained the issue and explained that if their Radixact System is being serviced by a third-party provider, please ensure they are also aware and take relevant precautions while servicing the system. The product impacted by the issue was detailed. The letter explained the issue arises only during the servicing of the Radixact System and customers can continue the clinical use of their system. The letter informs the consignee that Accuray will inspect the upper roller brac |
| Quantity | 82 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161146 | Radixact Treatment Delivery System Accuray Incorporated, Jun 24, 2016 |