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 | |
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