Device product

RefleXion Medical Radiotherapy System - System Label: "* refleXion REF RXM1000 *" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"

Z-0470-2022

November 24, 2021

Class II

Product summary

Firm: Reflexion Medical, Inc.
Event: Event 89212
Status: Terminated
Classification: Class II
Quantity: 3 devices
Official record key: device-enforcement:Z-0470-2022

Official wording

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).

Code information: 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

Distribution pattern: U.S. Nationwide distribution in the states of CA and TX

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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).