Vero Biotech has recalled its GENOSYL DS nitric oxide delivery system for critically ill newborns because of a software error that could lead to serious injury or death.

The device, which delivers nitric oxide that helps open blood vessels and improve oxygen levels in newborns with respiratory failure, is used with a ventilator in hospital or other healthcare settings.

The software error that led to the recall has “caused delivery of lower-than-expected dosage of nitric oxide during the transition between primary and backup console,” the FDA said in a notice on the Class 1 recall. The agency noted that there have been 11 reported complaints, including three injuries, linked to the recalled product.