Device product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026
Product summary
- Firm
- NOXBOX LTD
- Event
- Event 97516
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1667 units
- Official record key
device-enforcement:Z-0029-2026
Official wording
Reason: 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.
Code information: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Distribution pattern: Domestic: TN;
Derived failure modes
-
Unknown
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.