Reflexion Medical, Inc.: Device Recall

Recall #Z-1933-2024 · 04/16/2024

Class II: Risk

Recall Details

Recall Number: Z-1933-2024
Classification: Class II
Product Type: Device
Recalling Firm: Reflexion Medical, Inc.
Status: Ongoing
Date Initiated: 04/16/2024
Location: Hayward, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7 systems

Reason for Recall

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

Product Description

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.

Distribution Pattern

U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.

Other Recalls by Reflexion Medical, Inc.

Class II: Risk 07/22/2025

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

View all recalls by Reflexion Medical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.