NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has announced a critical correction for its NOxBOXi Nitric Oxide Delivery System due to a potential safety issue related to rapid button pressing. The issue may lead to a software interruption, system restart, and serious risks for patients undergoing nitric oxide therapy. Clinical teams and healthcare facilities using this device are advised to take immediate actions to mitigate risks and ensure patient safety.
What changed?
On September 8, 2025, the manufacturer issued an urgent medical device correction to address concerns arising from rapid input of commands on the NOxBOXi’s on-screen interface. Rapidly pressing two or more buttons in quick succession can result in a software interruption and trigger an unexpected system restart. This malfunction could seriously impact patient therapy, particularly in critical care settings where nitric oxide therapy is administered.
As of September 9, 2025, two injuries were reported in connection to this issue, though no deaths have been attributed. The FDA has classified this correction as the most serious type of recall because failure to address the issue could result in serious injury or even death.
Who is affected?
The correction applies to all users of the NOxBOXi Nitric Oxide Delivery System in the United States. The affected model and identifiers include:
- Product Name: NOxBOXi Nitric Oxide Delivery System
- Unique Device Identifier (UDI): 05060541640009
- Model Numbers: MOXBOXI (NBL Manufacturer) and REQNOXBOXI (Linde U.S. Distributor)
- Affected Devices: All serial numbers
Recommended actions for users
The manufacturer has issued comprehensive guidance to help healthcare facilities and clinicians manage the device safely until a permanent fix is available. Key steps include:
- Avoid rapid, successive button presses on the NOxBOXi device to prevent triggering a software issue. Allow the device sufficient time to process each command before proceeding.
- If a “System Diagnostics” notification appears due to an unexpected system restart, follow these steps to resume therapy safely:
- Switch the device from Intelligent Mode to Manual Mode to continue nitric oxide delivery using the NOxMIXER.
- Select the red on-screen Restart button.
- Once the restart is complete, return to Intelligent delivery by selecting the “Skip to Dose” function.
- Ensure all affected personnel review the manufacturer’s recommendations issued in the Urgent Medical Device Correction letter.
Manufacturer response and next steps
NOxBOX Ltd. has committed to resolving this issue through the development of a new software version. Once the updated software is available, the company will contact customers to arrange for the necessary updates. This step aims to permanently address the software malfunction and prevent future interruptions caused by rapid command inputs.
How to report issues?
Health care professionals and consumers are encouraged to report any adverse reactions or quality concerns related to the NOxBOXi device to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program. Prompt reporting will help evaluate the effectiveness of corrective measures and identify any additional areas of concern.
Why is this correction critical?
The NOxBOXi Nitric Oxide Delivery System is designed to deliver and monitor precise concentrations of nitric oxide, as well as monitor nitrogen dioxide and oxygen levels, in patients’ respiratory systems. Interruptions in these functions can lead to severe adverse outcomes, including therapy interruption, changes in blood oxygen levels (desaturation), increased arterial pressure, and in extreme cases, death. These risks underline the importance of adhering to the manufacturer’s guidance and implementing the corrective actions immediately.
Conclusion
This correction highlights the importance of vigilance in medical device use and the need for healthcare professionals to closely follow manufacturer updates. NOxBOX Ltd. is actively working on a software fix to fully resolve this issue. Until then, all clinicians must exercise caution and follow the recommendations provided to ensure continued patient safety.
Disclaimer
This article is intended for professionals in clinical, quality, and regulatory roles. It is not a substitute for legal or regulatory consultation. Always refer to the official guidance and documentation provided by the FDA and the device manufacturer.