Reflexion Medical, Inc. Recall 89212
Description: RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Reflexion Medical, Inc. Recall 89212 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0470-2022 |
| Event ID | 89212 |
| Event Description | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA and TX |
| Quantity | 3 devices |
| Recall 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). |
| Device Classification | 20220119 |
| Device Code Info | Model: RXM1000 Serial Numbers/UDI Codes: X11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003 |
| Center Classification Date | 20220110 |
| Recall Initiation Date | 20211124 |
| Recalling Firm | Reflexion Medical, Inc. |
| Initial Notification | |
| Similar To |