RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionali…
Reflexion Medical, Inc. · A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Open FDA's page for this record- Cfres ID
- 207500
- Product res number
- Z-1933-2024
- Event date initiated
- 2024-04-16
- Event date posted
- 2024-05-30
- Recall status
- Open, Classified
- Res event number
- 94533
- Product code
- QVA
- Firm FEI number
- 3011716550
- Recalling firm
- Reflexion Medical, Inc.
- Address 1
- 25881 Industrial Blvd
- City
- Hayward
- State
- CA
- Postal code
- 94545-2991
- Additional info contact
- Diana King 650-248-5714
- Reason for recall
- A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- Root cause description
- Software design
- Product quantity
- 7 systems
- Distribution pattern
- U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
- 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.
- 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
- Action
On 04/29/2024, the firm sent an "Urgent: Medical Device Recall Safety Notification" via email to customer informing them that during internal dosimetric testing of SCINTIX OOS partials in periodic tracking mode, it was observed that the delivered dose error of the full fraction can exceed 5% with respect to the upper bound of one or more static volumes within the DVH in the plan (non-tracked, non-target volumes in the patient frame of reference, i.e., the planning CT). This was determined to be the result of a software defect associated with completing interrupted. Customers are instructed to: 1. Notify all clinical staff of this recall 2. Utilized the Clinical Guidance Document that is include with this notification. For questions or concerns - contact Service and Support at 650-239-9070 or email support@reflexion.com
- Harmonized identifiers (openFDA)
- Device name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Medical specialty description
- Radiology
- Regulation number
- 892.5060
- Device class
- 2
- K number
- DEN220014, K252071
- Registration number
- 3011716550
- FEI number
- 3011716550