FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1933-2024
·
Reported June 5, 2024
Enforcement
- Recall Number
- Z-1933-2024
- Event ID
- 94533
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Reflexion Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 5, 2024
- Initiation Date
- April 16, 2024
- Classification Date
- May 30, 2024
- Address
- 25881 Industrial Blvd, Hayward, CA, 94545-2991, United States
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
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Code Info
Model Number: RXM1000 UDI Codes that includes system serial numbers: (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 (01)00860003983812(11)230803(21)X11008
Distribution
U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Quantity
7 systems