RefleXion X1 radiation therapy system software configuration error causes excessive dose fractionation
RefleXion X1 Model RXM1000 radiation therapy systems may deliver excessive radiation due to a software configuration error that allows more than two fractions in 12 hours, potentially causing toxicity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall where a software configuration error could potentially cause excessive radiation delivery and toxicity. No injuries or hospitalizations have been reported, meeting the criteria for a high-risk product with theoretical potential for harm.
Plain-English summary
RefleXion X1 Model RXM1000 is a radiation therapy system that combines positron emission tomography imaging with a linear accelerator for cancer treatment. Eleven systems have been distributed nationwide in California, Connecticut, Louisiana, New Jersey, Oregon, Pennsylvania, and Texas.
The device is subject to recall due to an incorrect software configuration. The error could allow more than two radiation fractions to be delivered within a 12-hour period, potentially exceeding safe treatment limits and causing toxicity.
Patients receiving treatment with affected RefleXion X1 systems should contact their healthcare facility to understand the issue and discuss any necessary follow-up care. Affected systems can be identified by their unique device identifiers (UDI codes). Healthcare providers should contact Reflexion Medical, Inc. for software updates and further guidance.
The recalled product
- Product
- 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)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
- Manufacturer
- Reflexion Medical, Inc.
- Category
- Medical Device
- Hazard
- software-defect
- radiation-overdose
- toxicity
Distribution
Distributed nationwide across the United States.
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