Use caution Medical device recall · FDA · Published February 9, 2026

Reflexion X1 Radiotherapy System Software Defect May Cause Incorrect Dose Delivery

Reflexion Medical recalls X1 Radiotherapy System Model RXM1000 with software versions 2.1.29-4 and 2.1.35-1 due to potential dose misdelivery. Affected units may receive 5mm+ displacement or 10-20% underdose.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1656-2026Medical device Reflexion Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmReflexion Medical, Inc.25881 Industrial Blvd · Hayward, CA 94545-2991

✎ GovInfoNow plain-language explainer

Reflexion Medical is recalling its X1 Radiotherapy System Model RXM1000 with specific software versions because a software defect can cause radiation treatment to be delivered to the wrong body area. This could result in a 5mm or larger displacement of the treatment or a 10-20% underdose of radiation, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/50035-reflexion-x1-radiotherapy-system-software-defect-may-cause-incorrect-dose.

Source Summary by GovInfoNow · govinfonow.com/recall/50035-reflexion-x1-radiotherapy-system-software-defect-may-cause-incorrect-dose · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1656-2026

Cite this page

“Reflexion X1 Radiotherapy System Software Defect May Cause Incorrect Dose Delivery.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50035-reflexion-x1-radiotherapy-system-software-defect-may-cause-incorrect-dose. Based on FDA recall #Z-1656-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1656-2026%22&limit=1).

The FDA announced on Feb. 9, 2026, that Reflexion Medical, Inc. is recalling its RefleXion X1 Radiotherapy System Model RXM1000 due to a software defect that may deliver radiation doses to incorrect locations. The agency classified the recall as Class II.

How to tell if you have it

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Software Version: 2.1.29-4 and Software Version: 2.1.35-1
UPC: 00860003983812

The hazard

According to the FDA, when performing angular roll corrections followed by a repeat localization, the system fails to carry through initial roll corrections to treatment delivery. This may result in a displacement of 5mm or higher and a 10% to 20% underdose.

Context

GovInfoNow's records show Reflexion Medical, Inc. has 3 other recalls on record since 2021-11-24. Other recent recalls of similar products include RayStation 10B Software May Cause Radiation Dose Errors (2025-11-28), RayStation Software Recalls: Radiation Dose Calculation Errors in Some Regions (2025-11-28) and RayStation Software Version 12A Recalls: Radiation Dose Calculation Errors (2025-11-28).

How to tell if you have this one

Check if your X1 Radiotherapy System Model RXM1000 has software versions 2.1.29-4 or 2.1.35-1. The unique device identifier (UDI) codes listed in the recall notice also identify affected units.

Brand
Reflexion Medical
Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version matches the affected versions listed in the recall notice.
Contact Manufacturer
Reach out to Reflexion Medical for guidance on next steps if your system is affected.

Where it went and when

Where it was distributed

Distributed in 8 states.

FDA distribution: “US: CA, TX, PA, CT, NJ, OR, LA, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Connecticut, Louisiana, New Jersey, Ohio, Oregon, Pennsylvania, Texas.

Recall timeline

FDA published this recall 58 days after the firm started it.

Feb 9, 2026Firm started the recall
Mar 27, 2026FDA classified it Class II
Apr 8, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Reflexion Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/50035-reflexion-x1-radiotherapy-system-software-defect-may-cause-incorrect-dose">Reflexion X1 Radiotherapy System Software Defect May Cause Incorrect Dose Delivery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1656-2026 (February 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1656-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.