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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
Related recalls
Same manufacturer · Reflexion Medical, Inc.
See all →- HighRadiotherapy systems recalled over software allowing more than two daily fractions
FDA (Devices) · 2025-09-10
- HighRefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Error
FDA (Devices) · 2024-06-05
- HighRefleXion Medical Radiotherapy System Recall Due to Dose Discrepancy
FDA (Devices) · 2022-01-19
Same hazard · software defect
See all →- SeverePhilips Lumify Diagnostic Ultrasound System Recalled for Connection Issues
FDA (Devices) · 2026-10-28
- SevereMedtronic MiniMed Go App Recall for Insulin Dose Reminder Failure
FDA (Devices) · 2026-10-28
- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
Similar recalls
- HighRefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Error
FDA (Devices) · 2024-06-05
- HighRefleXion Medical Radiotherapy System Recall Due to Dose Discrepancy
FDA (Devices) · 2022-01-19
- HighRadiotherapy systems recalled over software allowing more than two daily fractions
FDA (Devices) · 2025-09-10
- HighRayStation Radiation Therapy System Recalled for Potential Dosing Error
FDA (Devices) · 2024-05-08
- HighRadiation Therapy System Software Issue May Cause Unexpected Dose
FDA (Devices) · 2023-03-15
- HighZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment
FDA (Devices) · 2022-09-21