ProductGuru Recalls

Official recall record

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

US FDA — Medical Devices · 2026-02-09 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2026-02-09
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
00860003983812
Brand on record
Reflexion Medical, Inc.

What the authority reported

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 to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.