Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1656-2026 — RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

U.S. FDA — Device Enforcement · United States · 2026-02-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1656-2026
Date of alert
2026-02-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Reflexion Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860003983812
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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