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

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1656-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

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

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:

  • CA
  • CT
  • LA
  • NJ
  • OH
  • OR
  • PA
  • TX

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