HIGH

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

Quick Facts at a Glance

Recall Date
February 9, 2026
Hazard Level
HIGH
Brand
Reflexion Medical
Geographic Scope
7 states

Hazard Information

Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Reflexion Medical, Inc. or your healthcare provider for instructions

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Full Description

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00. Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.. Classification: Class II. Quantity: 12. Distribution: US: CA, TX, PA, CT, NJ, OR, LA, OH

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001
(01)00860003983812(11)230518(21)X11002
(01)00860003983812(11)230505(21)X11003
(01)00860003983812(11)230530(21)X11004
(01)00860003983812(11)230811(21)X11006
+7 more
Affected States
CA, TX, PA, CT, NJ, LA, OH
Report Date
April 8, 2026
Recall Status
ACTIVE

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