CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
RefleXion X1 Radiotherapy System recalled by Reflexion Medical
Reflexion Medical is recalling RefleXion X1 Radiotherapy System, distributed in 8 states. The recall was initiated on 9 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1656-2026
- FDA event ID
- 98518
- Recalling firm
- Reflexion Medical, Hayward, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2026
- FDA classified
- 27 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2026 | Recall initiated by company | |
| 27 Mar 2026 | Classified by FDA | +46 days |
| 8 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Where it was distributed
US: CA, TX, PA, CT, NJ, OR, LA, OH
CaliforniaConnecticutLouisianaNew JerseyOhioOregonPennsylvaniaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, (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.
Where was it sold?
US: CA, TX, PA, CT, NJ, OR, LA, OH
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Reflexion Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RefleXion X1 recalled by Reflexion Medical | Reflexion Medical | Device Malfunction | Nationwide |
| Device | CLASS II | RefleXion X1 Radiotherapy System recalled by Reflexion Medical | Reflexion Medical | Device Malfunction | 6 states |
| Device | CLASS II | Radiotherapy System - System Label: "*** refleXion recalled | Reflexion Medical | Other | Nationwide |
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