CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
RefleXion X1 Radiotherapy System recalled by Reflexion Medical
Reflexion Medical is recalling RefleXion X1 Radiotherapy System, distributed in California, Connecticut, New Jersey, Oregon, Pennsylvania, Texas. The recall was initiated on 16 Apr 2024 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-1933-2024
- FDA event ID
- 94533
- Recalling firm
- Reflexion Medical, Hayward, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Apr 2024
- FDA classified
- 30 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 16 Apr 2024 | Recall initiated by company | |
| 30 May 2024 | Classified by FDA | +44 days |
| 5 Jun 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
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 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
Where it was distributed
U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Questions about this recall
Why was it recalled?
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Which lots are affected?
Model Number: RXM1000 UDI Codes that includes system serial numbers: (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
Where was it sold?
U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
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 Radiotherapy System recalled by Reflexion Medical | Reflexion Medical | Device Malfunction | 8 states |
| Device | CLASS II | RefleXion X1 recalled by Reflexion Medical | Reflexion Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Radiotherapy System - System Label: "*** refleXion recalled | Reflexion Medical | Other | Nationwide |
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