Reported Jan 19, 2022 · Terminated
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery…
Reflexion Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Reflexion Medical, Inc. · 25881 Industrial Blvd · Hayward, CA · 94545-2991
Is this the product you have?
- RefleXion Medical
- Radiotherapy System - System Label"*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User
- Manual/Treatment Planning User Manual"RefleXion
- X1 ModelRXM1000"
- Lot codes and dates
- ModelRXM1000
- Serial Numbers/UDI CodesX11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003
- Amount recalled
- 3 devices
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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