Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the…
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Read the official notice →- Date
- 2024-06-05
- Country
- United States
- Brand
- Reflexion Medical
- Product
- RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the…
- Classification
- Class II
- Units
- U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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- 2026-04-08
USReflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
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Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002…
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).
FDA · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.Official notice → - 2022-01-19
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FDA · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA and TXOfficial notice →
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