RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)

FDA device recall Z-2486-2025 · posted 2025-09-02 · Open, Classified

Recall details

Recalling firm

Reflexion Medical, Inc.

Reason for recall

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).

Action taken

On 07/22/2025, the firm sent an "Urgent Medical Device Recall Safety Notification (Correction)" Letter to customer informing them that RefleXion is initiating a Recall (Correction) of the RefleXion X1 System (model RXM1000). An issue has been identified with a configuration setting for the maximum number of fractions that can be delivered within a specified time period. The system should be configured to allow the delivery of up to two (2) fractions, including completion of partial fractions, for each treatment plan within a 12-hour period. As a result of this issue there is a potential to unintentionally administer more than two treatments in a 12-hour period, potentially leading to serious toxicity. Customer are instructed to: 1) Acknowledge receipt of the email by signing and returning the attached Consignee Acknowledgment Form at their earliest convenience. 2) Until the configuration setting is corrected, RefleXion Medical advises users to employ current radiation therapy procedures within the clinic to perform daily checks of treatment session records for radiation therapy patients to prevent delivery of unintended fractions. 3) It is requested that customers post this notification on or near the RefleXion Medical RXM1000 system until this issue can be resolved. For questions or assistance - email support@reflexion.com

Root cause

Software change control

Status

Open, Classified

Product code

QVA

Quantity affected

11

Distribution

U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.

Date initiated

2025-07-22

Date posted

2025-09-02

Location

Hayward, CA