Quick Facts at a Glance
- Recall Date
- February 9, 2026
- Hazard Level
- HIGH
- Brand
- Reflexion Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 7 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Reflexion Medical
- Product type
- Radiotherapy System
- Model numbers
- 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 +4 more
- Sold at
- Unknown
- Where affected
- CA, TX, PA, CT, NJ, LA, OH
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 9, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Reflexion Medical, Inc. or your healthcare provider for instructions
About This Product
The RefleXion X1 Radiotherapy System is a high-precision device used in cancer treatment to deliver targeted radiation therapy. It is deployed in hospitals and cancer centers under physician supervision.
Why This Is Dangerous
A software defect during correction steps can cause roll corrections from the initial localization to not carry through to treatment delivery. This can shift the radiation dose away from the intended target by about 5 mm or more and reduce the delivered dose by 10% to 20%.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall creates a potential safety risk for patients undergoing radiotherapy and imposes operational considerations for hospitals, without any reported injuries to date.
Practical Guidance
How to identify if yours is affected
- Confirm device is RefleXion X1 RXM1000 with Part number 800-00006-00.
- Check software version for 2.1.29-4 or 2.1.35-1.
- Review listed UDIs associated with the device.
- Verify distribution location matches the states listed in the recall data.
- If affected, contact Reflexion Medical and halt use as directed.
What timeline to expect
Remediation timelines vary by hospital and vendor processes. No consumer refund timeline is provided for this medical device recall.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact Reflexion Medical for official guidance
- Report concerns to the FDA if the manufacturer is unresponsive
How to prevent similar issues
- Require vendor-provided software validation before clinical deployment
- Maintain updated device documentation and recall communications
- Standardize risk assessments for all radiotherapy devices
Documentation advice
Keep a copy of the recall notice, device serial numbers, software versions, UDIs, and all correspondence with the manufacturer and hospital leadership.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model: RefleXion X1 Radiotherapy System RXM1000; Part #: 800-00006-00. Sold to hospitals and healthcare providers in the United States. Quantity: 12 units. No price information available.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model RXM1000, Part 800-00006-00
- Software Versions: 2.1.29-4 and 2.1.35-1
- UDI examples: 01 00860003983812 11 230504 21 X11001 and subsequent UDIs
- US distribution: CA, TX, PA, CT, NJ, OR, LA, OH
- Recall date: 2026-02-09; Report date: 2026-04-08
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
