Reflexion Medical, Inc.: RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X

Is my product affected?

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

• UPC 00860003983805

Check against the official notice below — it lists the full affected range.

What happened

Reflexion Medical is recalling three RefleXion X radiotherapy systems (model RXM1000) distributed in California and Texas. The systems can deliver incorrect radiation doses to patients when positioned in Feet First Supine orientation, which is a non-standard head-first positioning used during treatment planning. The affected devices have serial numbers X11001, X11002, and X11003.

The recall notice does not specify what actions affected consumers or healthcare facilities should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

Reason for recall: 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). Distribution: U.S. Nationwide distribution in the states of CA and TX Quantity: 3 devices 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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