Reflexion Medical, Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Reflexion Medical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Reflexion Medical, Inc. is recalling RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system i due to A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Recommended Action
Per FDA guidance
On 04/29/2024, the firm sent an "Urgent: Medical Device Recall Safety Notification" via email to customer informing them that during internal dosimetric testing of SCINTIX OOS partials in periodic tracking mode, it was observed that the delivered dose error of the full fraction can exceed 5% with respect to the upper bound of one or more static volumes within the DVH in the plan (non-tracked, non-target volumes in the patient frame of reference, i.e., the planning CT). This was determined to be the result of a software defect associated with completing interrupted. Customers are instructed to: 1. Notify all clinical staff of this recall 2. Utilized the Clinical Guidance Document that is include with this notification. For questions or concerns - contact Service and Support at 650-239-9070 or email support@reflexion.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, NJ, OR, PA, TX
Page updated: Jan 10, 2026