--- title: "Reflexion Medical, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Reflexion Medical, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/reflexion-medical-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Reflexion Medical, Inc. recall records **3** reported ongoing 4 records in this archive. Latest source date Feb 9, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 9, 2026 FDA device enforcement ### [RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00](https://isitonrecall.com/recall/fda-device-z-1656-2026-reflexion-x1-radiotherapy-system-model-rxm1000-part-800-00006-00/) 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 trea... Class II Reported ongoing Distribution: US: CA, TX, PA, CT, NJ, OR, LA, OH [Official source for RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1656-2026%22) Jul 22, 2025 FDA device enforcement ### [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)...](https://isitonrecall.com/recall/fda-device-z-2486-2025-reflexion-x1-model-rxm1000-udi-codes-01-00860003983812-11-230504-21-x11001-01-00860003983812-11-2305/) 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). Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX. [Official source for RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2486-2025%22) Apr 16, 2024 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-1933-2024-reflexion-x1-radiotherapy-system-model-rxm1000-software-version-2-1-19-3-radiation-therapy-system-is/) A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. Class II Reported ongoing Distribution: U.S.: CA, CT, NJ, OR, PA and TX No O.U.S. [Official source for RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1933-2024%22) Nov 24, 2021 FDA device enforcement ### [RefleXion Medical Radiotherapy System - System Label: "\*\*\* refleXion REF RXM1000 \*\*\*" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 ...](https://isitonrecall.com/recall/fda-device-z-0470-2022-reflexion-medical-radiotherapy-system-system-label-reflexion-ref-rxm1000-physics-guide-treatment-del/) 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). Class II Reported terminated Distribution: U.S. Nationwide distribution in the states of CA and TX [Official source for RefleXion Medical Radiotherapy System - System Label: "\*\*\* refleXion REF RXM1000 \*\*\*" Physics Gui...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0470-2022%22) ## Reasons in these listed records - 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 bein... - 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). - A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. - 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). These examples come from this result page and are not a ranking of every recall reason. ## Checking Reflexion Medical, Inc. ### Is there a recall on reflexion medical, inc. right now? This archive contains 4 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Reflexion Medical, Inc.](https://isitonrecall.com/check/?q=Reflexion%20Medical%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)