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. Source coverage and dates.

Records and reported status

FDA device enforcement

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 IIReported ongoing

Distribution: US: CA, TX, PA, CT, NJ, OR, LA, OH

Official source for RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
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)...

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 IIReported 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...
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 ...

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

Class IIReported 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...
FDA device enforcement

RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 ...

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 IIReported 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...

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.

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What if the search finds no matching record?

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Where can I find older records?

Use monthly 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.

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