Z-1656-2026 Class II Ongoing
FDA device recall Z-1656-2026 was initiated by Reflexion Medical, Inc. on February 9, 2026 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- February 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product Description
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reason for Recall
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 Pattern
US: CA, TX, PA, CT, NJ, OR, LA, OH
Code Information
Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (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, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013.