NOxBOXi Nitric Oxide Delivery System Software Malfunction Recall
NOXBOX LTD is recalling 1,667 units of the NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) due to a software fault causing unexpected system errors when multiple buttons are pressed rapidly. The FDA classified this as a Class I recall due to potential device malfunction risk.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for this device malfunction hazard requires a minimum Severe (4) rating per the rubric. Although no illnesses or injuries are reported, the regulatory classification reflects serious risk to health from potential device malfunction.
Plain-English summary
NOXBOX LTD is recalling 1,667 units of the NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) due to an internal software fault. When users rapidly press multiple buttons on the device interface without allowing the device to respond to prompts, the device may experience unexpected system diagnostic errors that could affect its functionality.
The affected devices were distributed within Tennessee. All units with Model Number NOXBOX-I and all serial numbers are included in this recall.
Users of this device should discontinue use and contact NOXBOX LTD or their authorized distributor for information about replacement, repair, or return procedures. Healthcare facilities should notify their staff and secure affected units to prevent continued use.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Manufacturer
- NOXBOX LTD
- Hazard
- software-fault
- system-malfunction
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:
- TN
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