Recall Z-1933-2024 ยท QVA Fludeoxyglucose F18-Guided Radiation Therapy System
Reflexion Medical, Inc.
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.
| Date | May 30, 2024 (initiated Apr 16, 2024) |
| Status | Open, Classified |
| Reason | A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. |
| Root cause | Software design |
| 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 |
| Quantity | 7 systems |
| Distribution | U.S.: CA, CT, NJ, OR, PA and TX No O.U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.