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FDA (Device enforcement)Recalled 2025-09-09class i

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

Hazard

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.

Details from the source

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. Distribution: Domestic: TN; Quantity: 1667 units Lot/code info: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

UPC codes

05060541640009

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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