medical Class II Updated 2022-01-19

Reflexion Medical, Inc. recalls RefleXion Medical Radiotherapy System - System Label: "*

Recalled Product

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

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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
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