Recall Z-1933-2024— Reflexion Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Reflexion Medical, Inc., initiated 2024-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 detection system and a linear accelerator.. Reason: A potential dose error exists for patients treated with an out of session SCINTIX partial fraction..
- Recalling firm
- Reflexion Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-16
- Firm location
- Hayward, CA, United States
Product description
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 detection system and a linear accelerator.
Reason for recall
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.