The Recall Desk
HighFDA (Devices)·Z-1656-2026·Announced 2026-04-08

RefleXion X1 may deliver radiotherapy dose to the incorrect location

RefleXion Medical is recalling the X1 Radiotherapy System because a software defect can mean angular roll corrections are not carried through to treatment delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: radiotherapy dose may be delivered off-target and underdosed, and no injuries are stated in the source.

Plain-English summary

RefleXion Medical, Inc. is recalling the RefleXion X1 Radiotherapy System, model RXM1000, part 800-00006-00, running software versions 2.1.29-4 and 2.1.35-1. About 12 units were distributed across eight US states. The FDA has classified this recall as Class II.

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. This leads to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5 mm or higher, with a 10% to 20% underdose.

Affected systems carry UDI 00860003983812 across twelve listed serial numbers beginning X11001.

Facilities can identify affected systems by the model, software version and serial number, and may contact RefleXion Medical, Inc. for further information.

The recalled product

Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Manufacturer
Reflexion Medical, Inc.
Category
Medical Device — Radiotherapy
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • (01)00860003983812(11)230518(21)X11002
  • (01)00860003983812(11)230505(21)X11003
  • (01)00860003983812(11)230530(21)X11004
  • (01)00860003983812(11)230811(21)X11006
  • (01)00860003983812(11)230410(21)X11007
  • (01)00860003983812(11)230803(21)X11008
  • (01)00860003983812(11)240528(21)X11009
  • (01)00860003983812(11)240820(21)X11010
  • (01)00860003983812(11)241107(21)X11011
  • (01)00860003983812(11)241206(21)X11012
  • (01)00860003983812(11)250731(21)X11013.

Distribution

Distributed in 8 states:

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