Radiotherapy systems recalled over software allowing more than two daily fractions
RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential toxicity from exceeding fraction limits and reports no injuries.
Plain-English summary
The RefleXion X1, model RXM1000, is being recalled. Affected units are identified by the UDI codes and serial numbers listed in the recall notice, including X11001 through X11006. The recall covers 11 units distributed in California, Connecticut, Louisiana, New Jersey, Oregon, Pennsylvania and Texas.
The recall was issued because of an incorrect software configuration that potentially allows more than two fractions within a 12-hour period, against the configured fraction limits, and could potentially lead to adverse events including toxicity. The FDA classified the action as Class II.
Radiotherapy centres operating these systems should follow the manufacturer's instructions for correcting the software configuration.
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.
- Hazard
- software-configuration
- overexposure-risk
- radiotherapy
- class-ii
Distribution
Distributed nationwide across the United States.
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