Recall Z-1656-2026 ยท QVA Fludeoxyglucose F18-Guided Radiation Therapy System
Reflexion Medical, Inc.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
| Date | Mar 27, 2026 (initiated Feb 9, 2026) |
| Status | Open, Classified |
| Reason | Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. |
| Root cause | Software change control |
| Action | On 2/9/2026, recall notices were emailed to customers who were informed of the following: How to recognize that the device may fail: Any patient treatment with a roll offset applied in a localization followed by a subsequent repeat localization within the same treatment session will be affected. For patient treatments that have already occurred, measuring the approximate distance off-axis (R) and the maximum roll offset value (., in radians) can provide an approximate displacement value (S) through a simple mathematical formula, which may be helpful in estimating the severity of the dose impa |
| Quantity | 12 |
| Distribution | US: CA, TX, PA, CT, NJ, OR, LA, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.