Reflexion Medical, Inc. recalls 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…
Read the official notice →- Date
- 2026-04-08
- Country
- United States
- Brand
- Reflexion Medical
- Product
- RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Classification
- Class II
- Units
- US: CA, TX, PA, CT, NJ, OR, LA, OH
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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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.
More Reflexion Medical recalls
- 2025-09-10
USReflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002…
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FDA · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.Official notice →- 2024-06-05
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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.
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- US
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FDA · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA and TXOfficial notice →
Other drugs & medical recalls in the United States
- 2026-04-08
- US
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Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
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