Hayward, CA, United States
Reflexion Medical, Inc. recalls
4 recalls recorded since 2018, most recently on 9 February 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 February 2026
- Reason
- 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.
- Distribution
- US: CA, TX, PA, CT, NJ, OR, LA, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1656-2026
- RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Ongoing Class II Medical devices
- Recall started
- 22 July 2025
- Reason
- Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
- Distribution
- U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2486-2025
- RefleXion X1 Model RXM1000 UDI Codes: (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(1
Ongoing Class II Medical devices
- Recall started
- 16 April 2024
- Reason
- A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- Distribution
- U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1933-2024
- 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.
Terminated Class II Medical devices
- Recall started
- 24 November 2021
- Terminated
- 8 July 2024
- Reason
- Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
- Distribution
- U.S. Nationwide distribution in the states of CA and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0470-2022
- RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.