RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combi

FDA device recall Z-1933-2024 · posted 2024-05-30 · Open, Classified

Recall details

Recalling firm

Reflexion Medical, Inc.

Reason for recall

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

Action taken

On 04/29/2024, the firm sent an "Urgent: Medical Device Recall Safety Notification" via email to customer informing them that during internal dosimetric testing of SCINTIX OOS partials in periodic tracking mode, it was observed that the delivered dose error of the full fraction can exceed 5% with respect to the upper bound of one or more static volumes within the DVH in the plan (non-tracked, non-target volumes in the patient frame of reference, i.e., the planning CT). This was determined to be the result of a software defect associated with completing interrupted. Customers are instructed to: 1. Notify all clinical staff of this recall 2. Utilized the Clinical Guidance Document that is include with this notification. For questions or concerns - contact Service and Support at 650-239-9070 or email support@reflexion.com

Root cause

Software design

Status

Open, Classified

Product code

QVA

Quantity affected

7 systems

Distribution

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

Date initiated

2024-04-16

Date posted

2024-05-30

Location

Hayward, CA