NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

FDA device recall Z-0029-2026 · posted 2025-10-06 · Open, Classified

Recall details

Recalling firm

NOXBOX LTD

Reason for recall

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

Action taken

On September 9, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers: Actions to be taken: - Customers should ensure that all affected personnel are provided with a copy of the recommendations in this letter. - Users should avoid rapidly pressing buttons in quick succession (e.g., go to next screen, accept a value, change a value, backing out, repeating this) as it is necessary to allow an opportunity for the device to respond to user inputs before the next command to avoid a potential software interruption and subsequent restart. - NOxBOX Ltd. is asking customers in the U.S. to return the attached response form to Linde Gas & Equipment as instructed on the form. Recalling firm actions: NOxBOX Ltd. is in the process of developing a new software version that will include a modification to the software to resolve this issue, which will be released pending required regulatory review and approval. Once the software version is released, NOxBOX Ltd. will be back in contact with you to update your device software. If you have any questions about this notice or need assistance, please reach out to your local Clinical Educator or the Customer Excellence Center at 1-833-NOX-VENT (669-8368) or at LG.US.NOXIVENT@Linde.com.

Root cause

Software design

Status

Open, Classified

Product code

MRN

Quantity affected

1667 units

Distribution

Domestic: TN;

Date initiated

2025-09-09

Date posted

2025-10-06

Location

Sittingbourne, United Kingdom

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