Recall record at a glance
| Official record | Z-1656-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Reflexion Medical, Inc. |
| Report date | Apr 8, 2026 |
| Recall initiation date | Feb 9, 2026 |
| Quantity | 12 |
| Location | Hayward, CA, United States |
Official product description
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Why the product was recalled
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.
Distribution information
US: CA, TX, PA, CT, NJ, OR, LA, OH
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: not stated.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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