Nitric oxide systems recalled over fault from rapid button presses
NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because a rapid succession of button selections can trigger an unexpected internal fault or system diagnostic error.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The NOxBOXi Nitric Oxide Delivery System, model NOXBOX-I, is being recalled over a user interface fault.
An unexpected internal fault or system diagnostic error can result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
The recall covers 1,667 units, distributed in Tennessee. The device carries model numbers NOXBOXI from the manufacturer and REQNOXBOXI from the US distributor. The FDA has classified the recall as Class I.
Clinicians using the system should follow the manufacturer's instructions and allow the device to respond to each prompt before making the next selection.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Manufacturer
- NOXBOX LTD
- Affected units
- 1,667
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Numbers: (1) NOXBOXI (NBL (Manufacturer))
- (2) REQNOXBOXI (Linde (U.S. Distributor))
- UDI-DI: 05060541640009
- All serial numbers.
Distribution
Distributed in 1 state:
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