Recall Z-0470-2022 ยท IYE Accelerator, Linear, Medical
Reflexion Medical, Inc.
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
| Date | Nov 24, 2021 |
| Status | Terminated |
| Reason | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS). |
| Root cause | Software design |
| Action | On 11/24/2021 and 12/02/2021, the firm emailed customers to inform them of an ongoing investigation a potential dose discrepancy while treating patients in an orientation other than Head First Supine (HFS), i.e., Feet First Supine (FFS) and Head First Prone (HFP) and Feet First Prone (FFP). On 12/22/2021, the firm sent an "Urgent Safety Notification" letter to customers informing them that the Recalling Firm has confirmed that a dose discrepancy exists for patients treated in any orientation other than Head First Supine (HFS). Customers are instructed, until the updated software is install a |
| Quantity | 3 devices |
| Distribution | U.S. Nationwide distribution in the states of CA and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190978 | RefleXion Medical Radiotherapy System Reflexion Medical, Inc., Mar 12, 2020 |