RefleXion X1 Radiotherapy System Model RXM1000 recallZ-1933-2024 · Reflexion Medical, Inc. · initiated Apr 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Reflexion Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
FDA root cause category: Software design
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-1933-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 16, 2024
- Posted by the FDA
- May 30, 2024
- Recalling firm
- Reflexion Medical, Inc.
- Quantity
- 7 systems
- Product code
- QVA
- Distribution
- U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RefleXion Medical Radiotherapy System RXM1000Reflexion Medical, Inc. · Fludeoxyglucose F18-Guided Radiation Therapy System3 recalls36 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page